Cobalt HF Quad CRT-D MRI SureScan recallZ-1480-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated Nov 5, 2020
Open, Classified
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
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
FDA root cause category: Process control
What the company is doing
On 05-Nov-2020, Medtronic initiated retrieval activities via verbal communication to consignees who were in possession of unused, affected devices according to Medtronic records. Consignees were advised to quarantine all affected devices within their possession. In the United States, a written communication was mailed to two (2) identified consignees on 24-Nov-2020, directing the return of all unused, affected devices.
Recall details
- Recall number
- Z-1480-2022
- Status
- Open, Classified
- Initiated by the company
- Nov 5, 2020
- Posted by the FDA
- Jul 28, 2022
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 3 units
- Product code
- NIK
- FDA submissions
- P010031S674
- Distribution
- US Nationwide distribution in the states of Indiana and CA.
Product description
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Code information (models, lots, serial numbers)
GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cobalt™ HF Quad CRT-D MRI SureScan™ DTPB2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls19 deaths868 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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