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Open, Classified

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

FDA Recall Z-0779-2024 · Posted 2024-01-22

Recalling FirmMedtronic Inc.
Recall StatusOpen, Classified
Product CodeLWS
Date Initiated2023-12-07
Product Quantity1 device

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.

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the state of Florida.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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