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

FDA Recall #Z-0779-2024 — Class II — December 7, 2023

Recall #Z-0779-2024 Date: December 7, 2023 Classification: Class II Status: Ongoing

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.

Recalling Firm

Medtronic Inc. — Mounds View, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1 device

Distribution

US Nationwide distribution in the state of Florida.

Code Information

UDI/DI 00763000178338, Serial Number RSL604096S

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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