Medtronic Recalls
157 recalls on record · November 11, 2015 to May 6, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 6, 2026Medical DevicesFDA
Medtronic, Inc. recalls Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial f
Hazard: Ventricular fibrillation (VF) occurred 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.
January 21, 2026Medical DevicesFDA
Medtronic Inc recalls Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060
Hazard: 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.
December 10, 2025Medical DevicesFDA
Medtronic, Inc. recalls Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product
Hazard: There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
July 30, 2025Medical DevicesFDA
Medtronic, Inc. recalls Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Cr
Hazard: 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.
July 30, 2025Medical DevicesFDA
Medtronic, Inc. recalls Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt
Hazard: 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.
July 23, 2025Medical DevicesFDA
Medtronic, Inc. recalls Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following softwar
Hazard: 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.
July 23, 2025Medical DevicesFDA
Medtronic, Inc. recalls Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software compo
Hazard: 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.
June 18, 2025Medical DevicesFDA
Medtronic, Inc. recalls Azure S DR MRI SureScan, Product number W3DR01
Hazard: 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.
September 25, 2024Medical DevicesFDA
Medtronic Inc. recalls 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORT
Hazard: 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.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTB
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
July 3, 2024Medical DevicesFDA
Medtronic Inc. recalls Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
Hazard: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.