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
FDA Recall Z-1527-2021 · Posted None
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Recalling FirmMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Recall StatusOpen, Classified
Product CodeNIK
Date Initiated2021-04-06
Product Quantity37690 units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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