Medtronic recalls certain implantable cardioverter defibrillators (ICDs) due to rare risk of reduced or no energy output during high voltage therapy. Affected models include DDPA2D4G COBALT XT DR MRI DF4 GOLD.
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 specific implantable cardioverter defibrillators (ICDs) that may have reduced or no energy output during high voltage therapy. This could potentially lead to ineffective treatment of heart conditions if the device fails to deliver necessary shocks.
The device uses a specific glassed feedthrough that may cause reduced or no energy output during high voltage therapy. This could result in the device failing to deliver necessary shocks for heart conditions during critical medical events.
People with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) using the recalled model numbers. Those with the specific lot and serial numbers listed are most at risk.
Check if your device has the model number DDPA2D4G COBALT XT DR MRI DF4 GOLD. Look for lot serial numbers: RSM616778S, RSM616777S, RSM611337S, RSM610606S, RSM611339S, RSM610608S, RSM611339S.
Identify your device model number and lot/serial numbers to confirm if it is affected.
The recall does not require immediate discontinuation of use. However, you should check if your device is affected and contact Medtronic for guidance.
The recall does not specify a remedy. Contact Medtronic directly to discuss next steps for affected devices.
Check for the model number DDPA2D4G COBALT XT DR MRI DF4 GOLD and the listed lot/serial numbers: RSM616778S, RSM616777S, RSM611337S, RSM610606S, RSM611339S, RSM610608S.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1724-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1724-2023 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.
