FDAFDA · Food and drugs·Recall number Z-0779-2024
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Published January 31, 2024 · Recall initiated: December 7, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Medtronic Inc.
- Distributor
- US Nationwide distribution in the state of Florida.
- Lot
- UDI/DI 00763000178338, Serial Number RSL604096S
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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