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Medtronic, Inc.

Medtronic, Inc. Recalls

All product recalls associated with Medtronic, Inc..

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Recall Summary

Total Recalls

606

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 561–580 of 606 recalls

Medtronic, Inc.: CATH. GUIDE 6F EBU4.0 110CM LA CATHETER LA6EBU40A LA 6F 1...

Potential for non-sterility due to loss of package integrity

FDAApr 5, 2006Nationwide• Medtronic, Inc.

Medtronic, Inc.: CATHETER SB6SR40 SB 6F 100CM S CATHETER SB6SR40 SB 6F 100...

Potential for non-sterility due to loss of package integrity

FDAApr 5, 2006Nationwide• Medtronic, Inc.

Medtronic, Inc.: 8F ZUMA 2 SR 3.5 SH 100CM Coronary Guiding catheter desi...

Potential for non-sterility due to loss of package integrity

FDAApr 5, 2006Nationwide• Medtronic, Inc.

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Medtronic Emergency Response Systems, Inc.: LIFEPAK 12 defibrillator/monitor

Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.

FDAMar 22, 2006Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 defibrillator/monitor

FDAMar 22, 2006Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 automatic external defibrillator

LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power.

FDAMar 16, 2006Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Paceart 2004 Second Edition & Paceart 2005 Firs...

The Paceart System could inappropriately insert data from a patient's Medtronic CareLink transmission into another patient's Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists.

FDAFeb 2, 2006Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Navigation, Inc: AxiEM EM Knee Kit, and associated workstation.

Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.

FDAFeb 1, 2006AZ, CA, CO +9 more• Medtronic Navigation, Inc

Medtronic Emergency Response Systems, Inc.: LIFEPAK 500 automated external defibrillator (AED)

Component leads may have intermittent connection to the printed circuit board assembly pads - which could render the device inoperative.

FDAFeb 1, 2006Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK EXPRESS defibrillator

One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.

FDAJan 31, 2006Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK CR Plus defibrillator

One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.

FDAJan 31, 2006Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Sofamor Danek USA Inc: 8mm SATELLITE Sphere CoCr contained in a SATELLITE Spin...

Device distribution without marketing clearance

FDAJan 14, 2006LA• Medtronic Sofamor Danek USA Inc

Medtronic Inc, Neurological & Spinal Division: Medtronic Activa Deep Brain Stimulation (DBS) system incl...

A safety concern exists regarding the Medtronic Activa Deep Brain Stimulation system instructions for performing MRI (magnetic resonance imaging). Medtronic's instructions have until now recommended a use of a displayed MRI head specific absorption rate (SAR) of not more than 0.4 W/kg. The recommended maximum displayed head SAR is now 0.1 W/kg.

FDANov 30, 2005Nationwide• Medtronic Inc, Neurological & Spinal Division

Medtronic Inc. Cardiac Rhythm Managment: Sigma implantable pulse generators (IPGs) dual Chamber Pa...

An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due to this issue.

FDANov 29, 2005Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc, Neurological & Spinal Division: Medtronic Model 37711 Restore Neurostimulator. The Resto...

A limited number of Model 37711 Restore Neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged when it may only be 80% to 90% recharged. This anomaly does not affect patient safety. This anomoly can be corrected by reprogramming the Restore Neurostimulator using specific software.

FDANov 22, 2005Nationwide• Medtronic Inc, Neurological & Spinal Division

Medtronic Emergency Response Systems, Inc.: standard (hard) paddles used with the LIFEPAK 12 defibril...

Potential for voltage pins in connector of therapy cable to break.

FDASep 2, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: QUIK-COMBO pacing/defibrillation/ECG (therapy) cables use...

Potential for voltage pins in connector of therapy cable to break.

FDASep 2, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: Hard shell carry case for the LIFEPAK 500 AED.

Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).

FDAJul 12, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 defbrillator/monitor

The defibrillator may not operate if the device is turned on during an AC Loss Alert.

FDAJun 17, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Maximo DR, model 7278 Single Chamber Implantabl...

Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.

FDAFeb 9, 2005Nationwide• Medtronic Inc. Cardiac Rhythm Managment