Death Possible Due To Medtronic Defibrillator Flaw, FDA Warns

MINNEAPOLIS — The U.S. Food and Drug Administration has issued a Class I recall — its most serious level — for 348,616 Medtronic defibrillators. Serious injury or death may occur from a flaw in the device, the agency warned.

Medtronic — a Minneapolis-based medical device company — reports 28 incidents, 22 injuries, and no deaths for the issue.

The recall includes Medtronic's Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with glassed feedthrough sold between Oct. 13, 2017, to June 9, 2023.

See a list of all devices impacted on the FDA website.

The devices "may deliver low or no energy output when high voltage therapy is needed," the FDA states.

"A reduced-energy shock, or no shock at all, may fail to correct a life-threatening arrhythmia, which can lead to cardiac arrest, other serious injury, or death. There are additional risks of harm if a patient with one of these devices needs additional surgical procedures to remove and replace the device."

Medtronic has sent its customers the following required actions for software issues related to the recall:

• Do not prophylactically replace devices for this issue.
• Program all high voltage therapy pathways B>AX in all therapy zones to minimize the risk of this issue.
• Prioritize reprogramming patients with a history of high voltage therapy and Rx1 programmed AX>B.
• Encourage patients with AX>B programming in any high voltage therapy sequence to attend their next scheduled follow-up in-clinic for device reprogramming.
• Remotely monitor patients following normal clinical protocol.
• Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue:
• A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy.
• Reduced- or no-energy high voltage therapy is displayed in Episode Text (regardless of programmed pathway)
• Please complete the confirmation form enclosed with the letter and email it to RS.FCACRM@medtronic.com to confirm receipt.

Customers with questions should contact Medtronic at 1-800-929-4043.