Medtronic recalls Cobalt HF Quad MRI SureScan CRT-D devices with possible missing welds that could cause device failure. Affected units have specific serial numbers and product numbers.
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
Medtronic is recalling certain Cobalt HF Quad MRI SureScan defibrillators with Cardiac Resynchronization Therapy (CRT-D) due to a potential missing weld that could cause device failure. This affects patients with specific serial numbers and product numbers.
The device may have a missing resistance spot weld (RSW) during manufacturing. This defect could lead to device failure, though the exact mechanism of failure isn't specified in the recall.
Patients with the recalled Cobalt HF Quad MRI SureScan CRT-D devices are affected. Those with the specific serial numbers RTO601595S and RTO601624S are most at risk.
Check for the product number DTPB2D4 and unique serial numbers RTO601595S or RTO601624S on the device. The device is a multiprogrammable cardiac monitor that regulates heart rate.
Look for product number DTPB2D4 and serial numbers RTO601595S or RTO601624S on the device.
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
Check for product number DTPB2D4 and serial numbers RTO601595S or RTO601624S on the device.
The recall record does not specify a remedy, so contact Medtronic directly for guidance.
We’ve drafted a message you can send Medtr: Cardiac Rhythm to request your refund or repair — edit it as you like.
Subject: Recall Z-1650-2021 — Medtr: Cardiac Rhythm Medtr: Cardiac Rhythm Hello, I own a Medtr: Cardiac Rhythm that is covered by recall Z-1650-2021 from Medtr: Cardiac Rhythm. 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.
