Cobalt HF CRT-D MRI SureScan recallZ-1650-2021 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated Apr 7, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
FDA root cause category: Process control
What the company is doing
During the week of 07-Apr-2021, Medtronic initiated retrieval activities for 1 device (1 US/0 OUS) for a consignee in possession of a potentially affected, non-implanted device according to Medtronic records. The Consignee was verbally notified that the consigned units was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The representative was made aware that a formal notification to customer regarding these immediate actions would follow once the engineering evaluations were complete. In the United States, beginning 20-Apr-2021, a formal Urgent Medical Device Recall notification was delivered via a field sales representative, to the consignee who was part of the retrieval activities initiated the week of 07-Apr-2021. This letter will also be mailed via UPS 2-day delivery. The Consignee will be asked to confirm receipt of the letter and that they have acknowledge the actions taken for the non-implanted, affected product.
Recall details
- Recall number
- Z-1650-2021
- Status
- Terminated
- Initiated by the company
- Apr 7, 2021
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 2 units
- Product code
- NIK
- FDA submissions
- P010031S674
- Distribution
- US Nationwide distribution in the state of North Carolina.
Product description
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
Code information (models, lots, serial numbers)
Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cobalt™ HF CRT-D MRI SureScan™ DTPB2D4Medtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls5 deaths179 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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