Reported Jun 3, 2020 · Ongoing
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Heartware, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 HVAD Pump Implant Kit, Product (REF) Number 1104
- Lot codes and dates
- GTIN 00888707002028
- Serial Numbers
534 of 534 codes
HW28848hw29011HW29154HW29211HW29248HW29249HW29273HW29329HW29426HW29465HW29472HW29522HW29534HW29548HW29549HW29567HW29588HW29593HW29602HW29612HW29667HW29700HW29786HW29815HW29915HW29928HW29949HW30039HW30082HW30083HW30150HW30153HW30208HW30211HW30226HW30320HW30342HW30358HW30360HW30363HW30378HW30380HW30382HW30390HW30398HW30400HW30402HW30406HW30410HW30430HW30475HW30484HW30494HW30498HW30595HW30596HW30597HW30601HW30604HW30651
- Serial Numbers
85 of 85 codes
HW28851HW29783HW29793HW29794HW29827HW29870HW29918HW30045HW30046HW30505HW30765HW30842HW30844HW30845HW30846hw30978HW31075HW31077HW31080hw31089hw31091HW31095HW31161HW31342HW31348HW31555HW31556HW31557HW31683HW31860HW31903HW31920HW31924HW31926HW32026HW32027HW32028HW32149HW32153HW32163HW32282HW32513HW32514HW32562HW32563HW34004HW34006HW34091HW34092HW34125HW34272HW34273HW34274HW34349HW34350HW34351HW34352HW34357HW34358HW34359
- Serial Numbers
249 of 249 codes
HW29132HW29232hw29653HW29682HW29684HW29705HW29864HW29985HW29991HW30096HW30100HW30145HW30146HW30373HW30374HW30421HW30525HW30529HW30726HW30738HW30836HW30840HW30862HW30939hw30949hw30950HW31048HW31071HW31082HW31088hw31133hw31394HW31415HW31417HW31420HW31421HW31423hw31483hw31505hw31506hw31507hw31510HW31511hw31512hw31513hw31515hw31516hw31517HW31546HW31551HW31554HW31566HW31587HW31588HW31589HW31590HW31592HW31632HW31639HW31685
- Serial Numbers
HW29203HW29425HW29427HW29428HW29430HW29439HW29517HW29679HW29680HW30589HW30638HW30706HW30876HW31144HW31187hw31376hw31380HW31442HW31727HW31998HW32023HW32416HW34017 GTIN 00888707002417
- Serial Numbers
HW29478HW30381HW30831HW34380HW34421HW35348HW35613HW35756HW35761HW35763 GTIN 00888707002493
- Serial Numbers
HW29483HW29697HW29698hw31178HW31520HW31821HW31823HW31827HW32086HW32242HW32246HW32518HW32519HW34021HW34365HW34367HW34792HW34915HW35155HW35158HW35252HW35343HW35345HW35346HW35350HW35400HW35401HW35529HW35530HW35574HW35591HW35660HW35661HW35785 GTIN 00888707002400
- Serial Numbers
HW29518HW29693HW30092HW32257HW34012HW34210HW35034HW35154HW35573HW35653 GTIN 00888707002547
- Serial Numbers
HW29561HW29601HW29931HW30502HW30593HW30619HW30632HW30783HW30796HW30819HW30826HW31136HW31140HW31141HW31156HW31157HW31158HW31382HW31393HW31406HW31408HW31413HW31416HW31426HW31429HW31553HW31791HW31937HW31994HW32118HW32269HW32309HW32336HW32347HW32373HW32385HW32522HW32523HW32524HW32554HW32557HW34003HW34007HW34008HW34049HW34050HW34053HW34054HW34382HW34383HW34513HW34514HW34516HW34517HW34518HW35251HW35275 GTIN 00888707000680
- Serial Numbers
HW29571HW29578HW29845HW30635HW30639HW30711HW31150 GTIN 00888707002394
- Serial Numbers
HW30469HW30506HW30508HW30509HW30510HW30511HW30512HW30655HW31580HW31582HW31583HW31584HW31992HW31993HW32200HW32207HW32217HW32238HW32239HW32240HW32515HW32517HW34022HW34023HW34395HW34461HW34557HW34561HW34582HW34751HW34950HW34955HW34991HW34996HW35016HW35149HW35150HW35186HW35336HW35386HW35397HW35484HW35509HW35510HW35538HW35566HW35609HW35610HW35611HW35648HW35649HW35651HW35679HW35699HW35700HW35706HW35776HW35779 GTIN 00888707000239
- Serial Numbers
HW30634HW30645HW30877HW34737 GTIN 00888707002530
- Serial Numbers
HW30797HW31108HW31440HW31828HW31928HW32182HW32253HW32263HW34559HW35000HW35162HW35532HW35533HW35590 GTIN 00888707002523
- Serial Numbers
HW30859HW31703HW31704HW31859HW32030HW32036HW32040HW32102HW32520HW32521HW34018HW34020HW34027HW34028HW34986HW35040HW35043HW35049HW35216HW35217HW35218HW35490HW35531HW35619HW35786 GTIN 00888707002431
- Serial Numbers
hw30979hw31123HW32029HW32180HW34024HW34381HW34615HW35119HW35733 GTIN 00888707002585
- Serial Numbers
hw31079hw31081hw31168hw31170HW35095HW35164HW35351HW35353HW35355HW35496HW35497HW35575HW35576 GTIN 00888707002516
- Serial Numbers
hw31147hw31162HW32507HW34524HW35474 GTIN 00888707006330
- Serial Numbers
216 of 216 codes
HW31419HW31699HW31733HW32505HW35393HW35396HW35726HW35749HW35766HW35769HW35784HW35829HW35872HW36005HW36007HW36008HW36009HW36010HW36013HW36014HW36015HW36018HW36019HW36020HW36021HW36067HW36068HW36069HW36070HW36071HW36131HW36132HW36138HW36174HW36175HW36176HW36177HW36178HW36179HW36180HW36182HW36184HW36185HW36186HW36192HW36193HW36194HW36195HW36196HW36197HW36198HW36199HW36200HW36201HW36224HW36225HW36226HW36227HW36228HW36229
- Serial Numbers
183 of 183 codes
HW31444HW31569HW31673HW31814HW31817HW31818HW31820HW31824HW31825HW31826HW31872HW31873HW31875HW31877HW31927HW31932HW31934HW31939HW31940HW31941HW31995HW31996HW31997HW31999HW32002HW32008HW32009HW32010HW32011HW32013HW32032HW32034HW32038HW32046HW32053HW32057HW32062HW32065HW32071HW32085HW32109HW32165HW32166HW32195HW32205HW32211HW32221HW32236HW32243HW32250HW32506HW34015HW34122HW34123HW34124HW34251HW34252HW34275HW34277HW34280
- Serial Numbers
HW31586HW31700HW32035 GTIN 00888707002424
- Serial Numbers
HW31698HW31851 GTIN 00888707002448
- Serial Numbers
HW31779HW31780HW32546HW34095HW34617HW35398HW35511HW35589HW35597 GTIN 00888707002455
- Serial Numbers
HW31852HW31856HW32025HW32198HW34026HW34637HW35544 GTIN 00888707006019
- Serial Numbers
HW31983HW34720HW34974HW35376HW35377HW35849HW35866HW35869HW35871HW35873HW35877HW35878HW35879HW35880HW35998HW36000HW36056HW36057HW36058HW36059HW36060HW36061HW36062HW36063HW36113HW36114HW36115HW36116HW36117HW36118HW36119HW36120HW36145HW36146HW36155HW36156HW36157HW36158HW36159HW36167HW36221HW36222HW36223HW36350HW36351HW36352 GTIN 00888707006408
- Serial Numbers
HW34292HW35932HW36083HW36084HW36087HW36129HW36130HW36171HW36172HW36173HW36212HW36247HW36250HW36261HW36263HW36264HW36265HW36266HW36348HW36349HW36413HW36414HW36415HW36416HW36594HW36638 GTIN 00888707002554
- Serial Numbers
HW34337HW34362HW34484HW34591HW34594HW34625HW34682HW34693HW34732HW34833HW34838HW34846HW34876HW34884HW34889HW35052HW35057HW35061HW35067HW35316HW35323HW35359HW35362HW35363HW35364HW35458HW35536HW35585HW35620HW35622HW35623HW35709HW35710HW35728HW35732HW35758HW35759HW35764HW35767HW35771HW35772HW35775HW35777HW35780HW35782 GTIN 00888707004558
- Serial Numbers
HW34759HW34785HW35655HW35656 GTIN 00888707002141
- Serial Numbers
HW34848HW34849HW35711 GTIN 00888707006323
- Serial Numbers
191 of 191 codes
HW34982HW35031HW35379HW35380HW35381HW35382HW35383HW35384HW35388HW35389HW35390HW35391HW35392HW35621HW35642HW35654HW35712HW35722HW35727HW35729HW35736HW35755HW35770HW35781HW35783HW35977HW36024HW36025HW36027HW36028HW36029HW36030HW36032HW36033HW36034HW36042HW36043HW36044HW36045HW36046HW36064HW36065HW36072HW36073HW36074HW36075HW36076HW36077HW36078HW36079HW36080HW36081HW36082HW36123HW36124HW36125HW36126HW36127HW36128HW36133
- Serial Numbers
85 of 85 codes
HW35279HW35331HW35503HW35524HW35581HW35675HW35715HW35720HW35739HW35768HW35787HW35788HW35789HW35790HW35791HW35792HW35793HW35794HW35795HW35796HW35797HW35798HW35799HW35821HW35822HW35823HW35824HW35825HW35826HW35827HW35831HW35833HW35834HW35835HW35836HW35837HW35838HW35839HW35840HW35841HW35842HW35843HW35844HW35845HW35846HW35883HW35887HW35888HW35889HW35890HW35891HW35892HW35893HW35894HW35895HW35896HW35897HW35898HW35900HW35905
- Serial Numbers
HW35741HW35773 GTIN 00888707006316
- Serial Numbers
HW35754HW35774HW35865HW35868HW35874HW35940HW35958HW35962HW35963HW35964HW35965 GTIN 00888707005968
- Serial Numbers
70 of 70 codes
HW35801HW35802HW35803HW35804HW35805HW35806HW35807HW35808HW35809HW35810HW35811HW35812HW35813HW35814HW35815HW35816HW35817HW35818HW35819HW35820HW35847HW35848HW35850HW35851HW35852HW35853HW35854HW35855HW35856HW35857HW35858HW35859HW35860HW35861HW35862HW35863HW35864HW35867HW35870HW35875HW35923HW35924HW35927HW35929HW35931HW35935HW35936HW35937HW35938HW35939HW35966HW35967HW35968HW35969HW35970HW35971HW35972HW35973HW35975HW35976
- Serial Numbers
HW35876HW35882HW35884HW35885HW35886HW35941HW35942HW35999 GTIN 00888707006347
- Serial Numbers
86 of 86 codes
HW35902HW35903HW35908HW35909HW35910HW35911HW35912HW35913HW35914HW35915HW35918HW35920HW36001HW36002HW36003HW36016HW36035HW36036HW36037HW36038HW36039HW36040HW36048HW36049HW36050HW36051HW36052HW36053HW36054HW36055HW36088HW36089HW36092HW36093HW36094HW36095HW36096HW36097HW36100HW36101HW36102HW36103HW36105HW36106HW36107HW36108HW36109HW36110HW36111HW36112HW36170HW36540HW36541HW36542HW36543HW36544HW36565HW36566HW36568HW36569
- Serial Numbers
HW35979HW35980HW35982HW35984HW36160HW36161HW36162HW36163HW36164HW36278HW36287HW36381HW36382HW36383HW36384HW36385HW36386HW36387HW36388HW36460HW36462HW36464HW36465HW36469HW36470HW36471HW36472HW36480HW36481HW36482HW36483HW36484HW36486HW36487HW36489HW36491HW36492HW36494HW36495 GTIN 00888707006392
- Serial Numbers
HW35986HW35987HW36066HW36085HW36086HW36213HW36214HW36215HW36216HW36217HW36218HW36219HW36220HW36289HW36311HW36417HW36418HW36517HW36587HW36588HW36589HW36590HW36652HW36656HW36860 GTIN 00888707007290
- Serial Numbers
HW36421HW36422 GTIN 00888707006354
- Serial Numbers
HW36838HW36880 No GTIN
- Serial Numbers
HW26099HW26126HW26330HW26660HW26939HW26940HW27099HW27452HW27678HW28063HW28199HW28373HW28418HW28895HW28973HW29073HW29214HW29298HW29318HW29351HW29353HW29354HW29359
- Amount recalled
- 2225 Units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
Stop using this product now
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
Using this product could cause serious injury, illness or death — stop using it now.
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.
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