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U.S. Department of Health and Human Services

Class 2 Device Recall Cobalt

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  Class 2 Device Recall Cobalt see related information
Date Initiated by Firm November 05, 2020
Date Posted July 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-1480-2022
Recall Event ID 90429
PMA Number P010031S674 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
Product Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Code Information GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
Recalling Firm/
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact
Manufacturer Reason
for Recall
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
FDA Determined
Cause 2
Process control
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.
Quantity in Commerce 3 units
Distribution US Nationwide distribution in the states of Indiana and CA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = NIK and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = NIK and Original Applicant = Medtronic, Inc.