Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Brand
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Lot Codes / Batch Numbers
GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
Products Sold
GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) due to Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026