Medtronic Inc.: Medical Device Recall in 2024 - (Recall #: Z-0779-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 7, 2023

Date Posted: January 31, 2024

Recall Number: Z-0779-2024

Event ID: 93663

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.

Status: Ongoing

Product Quantity: 1 device

Code Information:

UDI/DI 00763000178338, Serial Number RSL604096S

Distribution Pattern:

US Nationwide distribution in the state of Florida.

Voluntary or Mandated:

Voluntary: Firm initiated