Medtronic recalls certain implantable cardioverter defibrillators (ICDs) due to rare risk of reduced or no energy output during high voltage therapy. Affected models include DDPA2D1G COBALT XT DR MRI DF1 GOLD with specific lot numbers.
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) that have a rare risk of reduced or no energy output during high voltage therapy. This could potentially lead to ineffective treatment if the device fails to deliver necessary shocks during a medical emergency.
The device uses a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy. This could mean the device doesn't deliver necessary shocks during a medical emergency, potentially leading to ineffective treatment.
People with Medtronic ICDs or CRT-Ds using the specific model number DDPA2D1G COBALT XT DR MRI DF1 GOLD are affected. Those with the listed lot serial numbers are at the highest risk.
Check your device's model number and lot serial numbers. Affected models include DDPA2D1G COBALT XT DR MRI DF1 GOLD with lot serial numbers RSL602260S, RSL602263S, or RSL602265S.
Identify your device's model number and lot serial numbers to see if they match the affected models listed.
The recall does not require immediate stop use; the hazard is rare and the device may continue to function safely.
The recall does not specify a remedy, so contact Medtronic directly for guidance.
Check your device's model number and lot serial numbers. Affected models include DDPA2D1G COBALT XT DR MRI DF1 GOLD with lot serial numbers RSL602260S, RSL602263S, or RSL602265S.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1722-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1722-2023 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.