Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 4,201–4,250 of 7,959

Medical Device Recall · December 18, 2024
Braemar Manufacturing, LLC
Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the monitoring service application software.
Class I
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ;
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emiss
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Class II
Medical Device Recall · December 18, 2024
Encore Medical, LP
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Class II
Medical Device Recall · December 18, 2024
Olympus Corporation of the Americas
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
Class I
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Class II
Medical Device Recall · December 18, 2024
Instrumentation Laboratory
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
Class II
Medical Device Recall · December 18, 2024
Tornier S.A.S.
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.
Class II
Medical Device Recall · December 18, 2024
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Class II
Medical Device Recall · December 16, 2024
Integra LifeSciences Corp.
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II
Medical Device Recall · December 16, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341; 3) MTO,ANGIO,SINGLE
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
Class I
Medical Device Recall · December 16, 2024
Olympus Corporation of the Americas
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
Potential for distal tip tearing of the Mechanical Lithotriptor V.
Class II
Medical Device Recall · December 16, 2024
Integra LifeSciences Corp.
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hyd
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II
Medical Device Recall · December 16, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
Class I
Medical Device Recall · December 16, 2024
Augustine Temperature Management, LLC
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia
There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
Class II
Medical Device Recall · December 16, 2024
Integra LifeSciences Corp.
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hyd
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Class II
Medical Device Recall · December 16, 2024
Augustine Temperature Management, LLC
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
Class II
Medical Device Recall · December 16, 2024
Augustine Temperature Management, LLC
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.
Class II
Medical Device Recall · December 15, 2024
Alphatec Spine, Inc.
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 d
Complaints have been received regarding post-operative implant collapse.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Descript
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 13, 2024
Hologic, Inc.
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Class II
Medical Device Recall · December 13, 2024
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dress
Potential for hole in package compromising sterility of the medical kit.
Class II
Medical Device Recall · December 12, 2024
LivaNova USA, Inc.
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Class II
Medical Device Recall · December 12, 2024
Abiomed, Inc.
Impella RP Flex with SmartAssist; Product Number: 1000323;
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Class I
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
Abiomed, Inc.
Impella RP with SmartAssist; Product Number: 0046-0035;
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Class I
Medical Device Recall · December 12, 2024
Medtronic Perfusion Systems
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
LivaNova USA, Inc.
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
Class II
Medical Device Recall · December 12, 2024
Medtronic Perfusion Systems
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 12, 2024
Medtronic Perfusion Systems
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class II
Medical Device Recall · December 12, 2024
Boston Scientific Corporation
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Class I
Medical Device Recall · December 11, 2024
Nuwellis Inc
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.
Class I
Medical Device Recall · December 11, 2024
MICROVENTION INC.
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coili
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Class II
Medical Device Recall · December 11, 2024
HF Acquisition Co LLC
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.
Class II
Medical Device Recall · December 10, 2024
ev3 Inc
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Class II