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Open, Classified

HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104

FDA Recall Z-1102-2022 · Posted None

Recalling FirmHeartware, Inc.
Recall StatusOpen, Classified
Product CodeDSQ
Date Initiated2022-03-30
Product Quantity236 units

Reason for Recall

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.

Firm Action

Starting 30-Mar-2022, Medtronic initiated an Urgent Medical Device Notice to VAD Coordinators at customer sites by regional mail and visit in order to inform them of the errors and the corrections impacting the incorrect translation in Finland and Turkey for the HVAD" System. In addition to the Urgent Medical Device Notice a patient template was provided to facilitate the VAD Coordinators in notifying their patients of the issues to the Patient Manual.

Root Cause

Labeling design

Distribution Pattern

Finland and Turkey

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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