# FDA recall Z-0779-2024

> **Medtronic Inc.** · Class II · device recall initiated 2023-12-07.

## Product

Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1

## Reason for recall

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.

## Distribution

US Nationwide distribution in the state of Florida.

## Key facts

- **Recall number:** Z-0779-2024
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-07
- **Report date:** 2024-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mounds View, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0779-2024

## Citation

> AI Analytics. FDA recall Z-0779-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0779-2024. Source: US FDA. Licensed CC0.

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