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Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy 

Medtronic is recalling all ICDs and CRT-Ds, manufactured after 2017, with a glassed feedthrough as they may deliver low or no energy output when needed for high voltage therapy. The issue is more likely to occur for devices with a glassed feedthrough configured to delivery therapy in the AX>B pathway.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

Questions?

Customers with questions about this recall should contact their Medtronic local representative or Technical Services at 1-800-929-4043.