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U.S. Department of Health and Human Services

Class 2 Device Recall Carelink

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  Class 2 Device Recall Carelink see related information
Date Initiated by Firm April 06, 2021
Create Date May 04, 2021
Recall Status1 Open3, Classified
Recall Number Z-1527-2021
Recall Event ID 87662
PMA Number P010031 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
Product Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure.
1. 2090 Carelink
2. 29901 Encore
Code Information all codes
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 Services
763-505-6000
Manufacturer Reason
for Recall		 A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
FDA Determined
Cause 2		 Software design
Action Beginning 06-APR-2021, Medtronic notified risk managers and practice managers of the field corrective action notification via 2- day UPS delivery of the consignee letter. Consignees were asked to confirm receipt of the notification. Medtronic Field Representatives have been instructed to begin installation of the software update. Outside the United States (OUS), communication began on 06- APR-2021 using locally approved methods. Confirmation will be obtained per locally approved methods. Medtronic Field Representatives will begin installation of the software update as it is available locally. A courtesy notification will be provided to physicians with affected devices.
Quantity in Commerce 37690 units
Distribution Worldwide distribution.
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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