Class II — Medtronic Inc.
| Recalling firm | Medtronic, Inc. |
|---|---|
| Registered facility | View this company's 53 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 |
| Quantity | 1 device |
| Distribution | US Nationwide distribution in the state of Florida. |
| Initiated | 2023-12-07 |
| Classified | 2024-01-22 |
| Recall number | Z-0779-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtronic Inc. (Z-0779-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93663/
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