Medtronic CRHF Cobalt HF Quad MRI Defibrillators: Missing Weld Risk
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.
Recall notice
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/62843-medtronic-crhf-cobalt-hf-quad-mri-defibrillators-missing-weld-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62843-medtronic-crhf-cobalt-hf-quad-mri-defibrillators-missing-weld-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1650-2021
Cite this page
“Medtronic CRHF Cobalt HF Quad MRI Defibrillators: Missing Weld Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62843-medtronic-crhf-cobalt-hf-quad-mri-defibrillators-missing-weld-risk. Based on FDA recall #Z-1650-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1650-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Medtr: Cardiac Rhythm- Category
Medical device
What to do — step by step
Check Device Details
Look for product number DTPB2D4 and serial numbers RTO601595S or RTO601624S on the device.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of North Carolina.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-1650-2021 (April 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1650-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.