Reported May 25, 2022 · Ongoing
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
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 Controller, Model Number 1407DE Kit
- Lot codes and dates
- GTIN 00888707001700
- Serial Numbers
192 of 192 codes
CON300826CON302649CON304346CON305438CON305669CON309302CON309306CON309974CON312894CON313111CON313129CON313154CON314788CON314789CON314903CON314929CON315066CON315120CON315384CON300826CON304248CON304346CON304363CON304943CON300612CON300622CON302530CON302655CON302814CON303005CON303057CON303093CON303132CON303368CON303549CON303571CON303936CON304027CON304028CON304282CON304302CON304318CON304322CON304327CON304328CON304358CON304360CON304362CON304381CON304451CON304453CON304587CON304596CON304600CON304610CON304614CON304620CON304628CON304645CON304649
- Serial Numbers
312 of 312 codes
CON315106CON315108CON315743CON315791CON315792CON315831CON316010CON316450CON316462CON316826CON317363CON317371CON317718CON318002CON318004CON318364CON318751CON318856CON318864CON318994CON319035CON319523CON319524CON319648CON400331CON400332CON400634CON400636CON400637CON400651CON401103CON401111CON401188CON401251CON401264CON401265CON401825CON402006CON402065CON402077CON402302CON402304CON402658CON402659CON402973CON402974CON403346CON403351CON403543CON403546CON403803CON403804CON403883CON403892CON403980CON403986CON404058CON405273CON405274CON405687
- Serial Numbers
CON410823CON410843CON410844CON410941CON410980CON410982CON411051CON411053CON411058CON411061CON411085CON411088CON411099CON411103CON411104CON411225CON411235CON411236CON411254CON411283CON411334CON411336CON411337CON411610CON411644 GTIN 00888707008242
- Serial Numbers
148 of 148 codes
CON412460CON412713CON412766CON412769CON412770CON412771CON412772CON412773CON412798CON412802CON412803CON412806CON412807CON412808CON412815CON412852CON412853CON412854CON412855CON412887CON412888CON412890CON412891CON412892CON412893CON412898CON412902CON412908CON412920CON412925CON412927CON412928CON412932CON412938CON412940CON412944CON412951CON412954CON412956CON412958CON412961CON412962CON412970CON413026CON413131CON413135CON413228CON413229CON413235CON413239CON413240CON413242CON413285CON413291CON413292CON413293CON413301CON413316CON413335CON413341
- Amount recalled
- 667 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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