Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1527-2021 — 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

U.S. FDA — Device Enforcement · United States · 2021-04-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1527-2021
Date of alert
2021-04-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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