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U.S. Department of Health and Human Services

Class 2 Device Recall Cobalt HF CRTD MRI SureScan

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 Class 2 Device Recall Cobalt HF CRTD MRI SureScansee related information
Date Initiated by FirmNovember 15, 2020
Create DateJanuary 26, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0927-2021
Recall Event ID 86887
PMA NumberP010031 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
ProductMedtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Code Information Serial Numbers: RTP601047S, RTP601055S
Recalling Firm/
Manufacturer		 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information ContactTechnical 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
ActionDuring 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 Commerce2 units
DistributionDistribution to US states of GA, PA, NJ, and France
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = NIK
PMAs with Product Code = NIK
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