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U.S. Department of Health and Human Services

Class 2 Device Recall Cobalt DR MRI SureScan

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  Class 2 Device Recall Cobalt DR MRI SureScan see related information
Date Initiated by Firm November 15, 2020
Create Date January 26, 2021
Recall Status1 Open3, Classified
Recall Number Z-0928-2021
Recall Event ID 86887
PMA Number P010031 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
Product Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Code Information Serial Numbers: RSN600251S, RSN600656S
Recalling Firm/
Manufacturer		 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact Technical Service
800-638-1991
Manufacturer Reason
for Recall		 Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
FDA Determined
Cause 2		 Process control
Action During the week of 15-Nov-2020, Medtronic initiated retrieval activities for 6 devices (5 US/1 OUS) for consignees in possession of potentially affected, non-implanted devices according to Medtronic records. Consignees were either verbally directed by Medtronic Field Representatives to quarantine product, or in the case of consigned units, the product was retrieved from consigned inventory and returned to Medtronic for engineering evaluation. The firm will follow with a letter to be disseminated on 12/04/2020 to the risk managers.
Quantity in Commerce 2 units
Distribution Distribution to US states of GA, PA, NJ, and France
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.
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