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Open, Classified

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)

FDA Recall Z-1480-2022 · Posted 2022-07-28

Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Recall StatusOpen, Classified
Product CodeNIK
Date Initiated2020-11-05
Product Quantity3 units

Reason for Recall

Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.

Firm Action

On 05-Nov-2020, Medtronic initiated retrieval activities via verbal communication to consignees who were in possession of unused, affected devices according to Medtronic records. Consignees were advised to quarantine all affected devices within their possession. In the United States, a written communication was mailed to two (2) identified consignees on 24-Nov-2020, directing the return of all unused, affected devices.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of Indiana and CA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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