Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0779-2024

December 07, 2023

Class II

Product summary

Firm
Medtronic Inc.
Event
Event 93663
Status
Ongoing
Classification
Class II
Quantity
1 device
Official record key
device-enforcement:Z-0779-2024

Official wording

Reason: 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.

Code information: UDI/DI 00763000178338, Serial Number RSL604096S

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.