Medtronic, Inc. Recalls

35 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (35)

March 11, 2026
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
Class II
December 4, 2025
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G1
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Class II
October 29, 2025
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Class II
June 18, 2025
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia appli
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
Class II
June 18, 2025
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia app
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
Class II
June 17, 2025
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Perce
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
Class II
June 17, 2025
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
Class II
April 29, 2025
Azure S DR MRI SureScan, Product number W3DR01
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
Class II
July 11, 2024
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c
Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.
Class II
April 16, 2024
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
April 16, 2024
Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class II
February 16, 2024
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
There is a potential for sterile package breach.
Class II
December 7, 2023
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
Class II
November 20, 2023
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Seal defects could compromise the ability of the product packaging to maintain sterility.
Class II

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