Reported May 25, 2022 · Ongoing
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD)…
Medtronic 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: Medtronic Inc · 710 Medtronic Pkwy Mailstop Ls245 · Minneapolis, MN · 55432-5603
Is this the product you have?
- Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed
- as part of the Pump Implant Kits models1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed
- with unique Catalog / Model Numbers
IFU00358IFU00375IFU00376GR00526IFU00520IFU00526IFU00593IFU00614M017475C001
- Lot codes and dates
- Device Model numbers affected1104: GTIN 00888707002028
- Serial Numbers
813 of 813 codes
HW28848HW29011HW29154HW29199HW29211HW29212HW29219HW29229HW29246HW29248HW29249HW29252HW29265HW29266HW29268HW29271HW29273HW29274HW29276HW29279HW29282HW29283HW29284HW29285HW29286HW29287HW29290HW29293HW29302HW29309HW29310HW29329HW29333HW29387HW29426HW29465HW29472HW29485HW29502HW29503HW29522HW29526HW29532HW29533HW29534HW29535HW29536HW29538HW29539HW29540HW29541HW29542HW29543HW29546HW29547HW29548HW29549HW29551HW29552HW29562
- Serial Numbers
HW41903HW41911HW41924HW41925HW41926HW41927HW41928HW41929HW41950HW41953HW42004HW42006HW42007HW42008HW42018HW42019HW42089HW42158HW42160HW42161HW42219HW42230HW42235HW42237HW42238HW42650HW42651HW42678HW42720HW42724HW42790HW42793HW42797HW42829HW42831HW43009GTIN 00888707003070
- Serial Numbers
66 of 66 codes
HW41892HW41894HW41895HW41897HW41899HW41900HW41901HW41932HW41934HW41936HW41937HW41938HW41939HW41940HW41941HW41971HW41972HW41973HW41974HW41975HW41977HW41986HW41991HW41993HW41994HW41997HW42000HW42001HW42002HW42005HW42009HW42021HW42022HW42026HW42099HW42101HW42103HW42104HW42110HW42111HW42114HW42116HW42148HW42153HW42155HW42157HW42223HW42225HW42228HW42229HW42232HW42233HW42252HW42291HW42307HW42326HW42328HW42329HW42330HW42331
- Serial Numbers
HW41961HW41962HW41964HW41965HW41966HW41967HW41968HW42313HW42660HW42663HW42671HW42672HW42901GTIN 00888707003117
- Serial Numbers
HW41955HW41957HW41958HW41959HW41960HW42023HW42024HW42025HW42061HW42091HW42130HW42292HW42335HW42337HW42339HW42647HW42665GTIN 00888707003209
- Serial Numbers
HW41915HW41916HW41918HW41919HW41945HW41946HW41947HW41948HW41978HW41979HW41981HW41982HW41983HW41984HW41988HW41990GTIN 00888707003254
- Serial Numbers
HW41943HW41944HW42213GTIN 00888707005968
- Serial Numbers
69 of 69 codes
HW35801HW35802HW35803HW35804HW35805HW35806HW35807HW35808HW35809HW35810HW35811HW35812HW35813HW35814HW35815HW35816HW35817HW35818HW35820HW35847HW35848HW35850HW35851HW35852HW35853HW35854HW35855HW35856HW35857HW35858HW35859HW35860HW35861HW35862HW35863HW35864HW35867HW35870HW35875HW35923HW35924HW35927HW35929HW35931HW35935HW35936HW35937HW35938HW35939HW35966HW35967HW35968HW35969HW35970HW35971HW35972HW35975HW35976HW35978HW35988
- Serial Numbers
320 of 320 codes
HW31419HW31699HW31733HW32505HW35393HW35396HW35562HW35571HW35726HW35749HW35766HW35769HW35784HW35829HW35872HW36005HW36006HW36007HW36008HW36009HW36010HW36013HW36018HW36019HW36020HW36021HW36069HW36070HW36071HW36131HW36132HW36138HW36174HW36175HW36176HW36177HW36178HW36179HW36180HW36184HW36185HW36186HW36192HW36193HW36194HW36195HW36197HW36198HW36199HW36200HW36201HW36224HW36225HW36226HW36227HW36228HW36229HW36230HW36231HW36232
- GTIN 00888707002639Serial
- Numbers
1,465 of 1,465 codes
HW28807R01HW28965HW29296HW29337R01HW29448HW29498R01HW29530HW29642R01HW29738HW29744HW29865R02HW29905R01HW29906HW29969HW30008HW30122HW30174HW30233HW30235HW30268R01HW30269R01HW30312HW30441HW30630HW30673HW30925HW31182HW31259HW31324HW31336HW30685HW30757HW31127hw31193HW31463HW29890HW30760HW30773HW30010HW30565HW30755HW31191HW31298hw31024HW30023R01HW30070HW30071HW30295HW30315HW30629HW30747HW31404HW30620HW29632HW29907HW30050HW30064HW30132HW30220HW30250
- GTIN 00888707003261Serial
- Numbers
718 of 718 codes
HW40229HW40405HW40436HW40567HW40568HW41753HW40261HW40601HW40717HW40764HW40880HW41248HW41446HW41692HW41296HW40977HW41061HW41478HW41488HW40145HW40209HW40264HW40299HW40301HW40381HW40389HW40455HW40524HW40527HW40620HW40640HW40643HW40734HW40737HW40738HW40762HW40834HW40288HW40326HW41752HW40222HW40223HW40443HW40922HW40504HW40575HW40576HW40822HW41100HW41118HW40569HW40694HW41823HW40147HW40635HW41476HW41584HW41586HW41588HW41797
- Amount recalled
- 21,118 pieces of product literature
Where it was sold
- Nationwide
Why it was recalled
Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.