—#205068

Product

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

FDA product code: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P980016S713
Affected lot / code info: UDI/DI 00763000178338, Serial Number RSL604096S

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc.
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: US Nationwide distribution in the state of Florida.

Timeline

Recall initiated: 2023-12-07
Posted by FDA: 2024-01-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205068. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.