Z-0779-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2024
- Initiation Date
- December 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 device
Product Description
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 Pattern
US Nationwide distribution in the state of Florida.
Code Information
UDI/DI 00763000178338, Serial Number RSL604096S