Medtronic recalls Cobalt HF CRT-D and Quad CRT-D models with potential reduced shock energy during high-voltage therapy. Affected units have specific model numbers and serial ranges. Users should contact Medtronic for replacement.
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Medtronic is recalling certain Cobalt HF CRT-D and Quad CRT-D defibrillators that may deliver reduced shock energy during high-voltage therapy. This could affect the device's ability to properly treat heart conditions. Affected models have specific serial numbers and GTINs listed in the recall.
The device may deliver only about 79% of the programmed shock energy during high-voltage therapy. This reduction could lead to inadequate treatment of heart conditions, potentially causing the device to fail to properly manage heart rhythm.
People with implanted Cobalt HF CRT-D or Quad CRT-D defibrillators that match the model numbers and serial ranges listed in the recall are most at risk. This includes individuals with heart failure who require cardiac resynchronization therapy.
Check if your device has model numbers DTPB2D4, DTPB2D1, DTPB2QQ, or DTPB2Q1. Look for specific GTINs and serial numbers listed in the recall document. The recall covers a range of serial numbers starting with 'RTO' or 'RTK' prefixes.
Reach out to Medtronic directly to confirm if your device is affected and to arrange for replacement or repair.
The recall affects Cobalt HF CRT-D models with model numbers DTPB2D4, DTPB2D1, and Cobalt HF Quad CRT-D models with model numbers DTPB2QQ and DTPB2Q1.
Check your device's model number and serial number against the specific GTINs and serial ranges listed in the recall document. Affected units have serial numbers starting with 'RTO' or 'RTK' prefixes.
No, but you should contact Medtronic to confirm if your device is affected and to arrange for replacement or repair.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1488-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1488-2022 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.
