Reported May 25, 2022 · Ongoing
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide…
Heartware, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heartware, Inc. · 14400 Nw 60th Ave · Miami Lakes, FL · 33014-2807
Is this the product you have?
- HeartWare Ventricular Assist Device (HVAD) System
- individual pamphletsHVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Instructions For Use (FI) HVAD¿ System Instructions For Use (FI) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Patient Manual (FI-Finnish) HVAD¿ System Instructions For Use - FI HVAD¿ System Instructions For Use (FI) HVAD¿ System OUS Patient Manual (FI-Finnish) HVAD¿ System Emergency Responder Guide (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System Patient Manual (TR-Turkish) HVAD¿ System OUS Instructions For Use (TR-Turkish)
- Lot codes and dates
24 of 24 products
Products covered by this recall # Product as published 1 Lot Number: R020776 HVAD System Emergency Responder Guide (FI-Finnish) 2 Lot Number: R020776 HVAD System Emergency Responder Guide (FI-Finnish) 3 Lot Number: R020776 HVAD System Emergency Responder Guide (FI-Finnish) 4 Lot Number: R025893 HVAD System Instructions For Use (FI) 5 Lot Number: R020771 HVAD System Instructions For Use (FI) 6 Lot Number: R020771 HVAD System Patient Manual (FI-Finnish) 7 Lot Number: R020769 HVAD System Patient Manual (FI-Finnish) 8 Lot Number: R020769 HVAD System Patient Manual (FI-Finnish) 9 Lot Number: R020769 HVAD System Patient Manual (FI-Finnish) 10 Lot Number: R020769 HVAD System Patient Manual (FI-Finnish) 11 Lot Number: R020769 HVAD System Patient Manual (FI-Finnish) 12 Lot Number: R020769 HVAD System Patient Manual (FI-Finnish) 13 Lot Number: R021391 HVAD System Patient Manual (FI-Finnish) 14 Lot Number: R021391 HVAD System Patient Manual (FI-Finnish) 15 Lot Number: R022265 HVAD System Instructions For Use - FI 16 Lot Number: R025606 HVAD System Instructions For Use (FI) 17 Lot Number: R028504 HVAD System OUS Patient Manual (FI-Finnish) 18 Lot Number: R028100 HVAD System Emergency Responder Guide (TR-Turkish) 19 Lot Number: R025877 HVAD System Patient Manual (TR-Turkish) 20 Lot Number: R021248 HVAD System Patient Manual (TR-Turkish) - Amount recalled
- 645 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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