Cobalt XT DR MRI SureScan recallZ-0779-2024 · Medtronic Inc. · initiated Dec 7, 2023
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. 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
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Medtronic hand delivered an Urgent Medical Device Recall/Retrieval notice to its sole consignee on 12/07/2023. The notice explained the issue and indicated that the device would be collected and a replacement provided.
Recall details
- Recall number
- Z-0779-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 7, 2023
- Posted by the FDA
- Jan 22, 2024
- Recalling firm
- Medtronic Inc.
- Quantity
- 1 device
- Product code
- LWS
- FDA submissions
- P980016S713
- Distribution
- US Nationwide distribution in the state of Florida.
Product description
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Code information (models, lots, serial numbers)
UDI/DI 00763000178338, Serial Number RSL604096S
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cobalt™ XT DR MRI SureScan™ DDPA2D1Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)5 recalls3 deaths241 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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