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

Recall Z-1106-2022 — HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH

U.S. FDA — Device Enforcement · United States · 2022-03-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1106-2022
Date of alert
2022-03-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Heartware, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00888707002868
Reported risk: Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
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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