MICROVENTION INC. Recalls
7 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (7)
- Class II
April 6, 2026
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
- Class II
September 5, 2025
Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED401
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.
- Class II
May 29, 2025
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.
- Class II
December 11, 2024
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
December 2, 2024
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
- Class II
August 5, 2024
ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by effectively removing clots from occlusive v
Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.
- Class II
December 21, 2023
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.