—#194374

Product

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

FDA product code: NIK — Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P010031S674
Affected lot / code info: GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Address: 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern: US Nationwide distribution in the states of Indiana and CA.

Timeline

Recall initiated: 2020-11-05
Posted by FDA: 2022-07-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194374. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.