Medtronic Inc.
37 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Medtronic Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-07-30FDA-DeviceClass IIMedtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
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.
- 2025-07-30FDA-DeviceClass IIMedtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
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.
- 2025-07-23FDA-DeviceClass IIMedtronic 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. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura applicati
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.
- 2025-07-23FDA-DeviceClass IIMedtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Sof
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.
- 2025-06-18FDA-DeviceClass IIAzure 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.
- 2024-09-25FDA-DeviceClass II2090 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) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Pro
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.
- 2024-07-03FDA-DeviceClass IIProduct 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 QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D4. f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1. g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ. h. COMPIA MRI QUAD
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- 2024-07-03FDA-DeviceClass IICROME 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.
- 2024-07-03FDA-DeviceClass IICOBALT 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.
- 2024-07-03FDA-DeviceClass IICobalt 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.
- 2024-07-03FDA-DeviceClass IICOBALT 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.
- 2024-07-03FDA-DeviceClass IICOBALT 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.
- 2024-07-03FDA-DeviceClass IICOBALT 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.
- 2024-07-03FDA-DeviceClass IIMIRRO 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.
- 2024-07-03FDA-DeviceClass IIMIRRO 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.
- 2024-07-03FDA-DeviceClass IIPRIMO 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.
- 2024-07-03FDA-DeviceClass IIMIRRO 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.
- 2024-07-03FDA-DeviceClass IIMIRRO 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.
- 2024-07-03FDA-DeviceClass IIPRIMO 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.
- 2024-07-03FDA-DeviceClass IIEVERA 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.
- 2024-07-03FDA-DeviceClass IIEVERA 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.
- 2024-07-03FDA-DeviceClass IIEVERA 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.
- 2024-07-03FDA-DeviceClass IIEVERA 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.
- 2024-07-03FDA-DeviceClass IICROME 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.
- 2024-07-03FDA-DeviceClass IICOBALT 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.
- 2024-07-03FDA-DeviceClass IICOBALT 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.
- 2024-07-03FDA-DeviceClass IICobalt 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.
- 2024-07-03FDA-DeviceClass IICOBALT 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.
- 2024-07-03FDA-DeviceClass IICOBALT 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.
- 2024-03-27FDA-DeviceClass IIAbre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
There is a potential for sterile package breach.
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