Crt-d Dtbb2qq Viva Quad S Is4/df4 Intl recall
CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators
Why was Crt-d Dtbb2qq Viva Quad S Is4/df4 Intl recalled?
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 00643169720176, Lot Serial Numbers: BLP603514S, BLP603579S, BLP603583S, BLP603637S, BLP603643S, BLP603554S, BLP603588S, BLP603580S, BLP603582S, BLP603584S, BLP603585S, BLP603586S, BLP603591S, BLP603531S, BLP603552S, BLP603511S, BLP603647S, BLP603581S, BLP603545S, BLP603551S, BLP603569S, BLP603648S, BLP603808S, BLP603536S, BLP603538S, BLP603542S, BLP603543S, BLP603544S, BLP603546S, BLP603549S, BLP603550S, BLP603553S, BLP603555S, BLP603557S, BLP603558S, BLP603562S, BLP603563S, BLP603576S, BLP603577S, BLP603587S, BLP603641S, BLP603670S, BLP603671S, BLP603672S, BLP603673S, BLP603674S, BLP603675S, BLP603676S, BLP603677S, BLP603678S, BLP603729S, BLP603730S, BLP603732S, BLP603733S, BLP603734S, BLP603735S, BLP603736S, BLP603409S, BLP603529S, BLP603533S, BLP603666S, BLP603689S, BLP603716S, BLP603758S, BLP603762S, BLP603786S, BLP603794S, BLP603795S, BLP603798S, BLP603801S, BLP603804S, BLP603807S, BLP603626S, BLP603627S, BLP603628S, BLP603629S, BLP603630S, BLP603631S, BLP603632S, BLP603633S, BLP603703S, BLP603704S, BLP603705S, BLP603706S, BLP603707S, BLP603709S, BLP603710S, BLP603711S, BLP603742S, BLP603747S, BLP603748S, BLP603779S, BLP603780S, BLP603781S, BLP603782S, BLP603783S, BLP603410S, BLP603512S, BLP603513S, BLP603517S, BLP603522S, BLP603523S, BLP603524S, BLP603526S, BLP603534S, BLP603590S, BLP603613S, BLP603634S, BLP603636S, BLP603652S, BLP603653S, BLP603657S, BLP603659S, BLP603660S, BLP603661S, BLP603662S, BLP603663S, BLP603664S, BLP603665S, BLP603667S, BLP603668S, BLP603669S, BLP603690S, BLP603712S, BLP603713S, BLP603715S, BLP603739S, BLP603740S, BLP603741S, BLP603763S, BLP603764S, BLP603765S, BLP603766S, BLP603769S, BLP603771S, BLP603772S, BLP603774S, BLP603775S, BLP603776S, BLP603777S, BLP603784S, BLP603785S, BLP603787S, BLP603788S, BLP603791S, BLP603792S, BLP603793S, BLP603796S, BLP603624S, BLP603625S, BLP603701S, BLP603702S, BLP603527S, BLP603698S, BLP603699S, BLP603700S, BLP603520S, BLP603521S, BLP603525S, BLP603717S, BLP603759S, BLP603768S, BLP603619S, BLP603620S, BLP603621S, BLP603622S, BLP603767S, BLP603623S, BLP603528S, BLP603714S, BLP603691S, BLP603692S, BLP603693S, BLP603694S, BLP603695S, BLP603696S, BLP603697S, BLP603789S, BLP603790S, BLP603530S, BLP603638S, BLP603639S, BLP603408S, BLP603635S, BLP603650S, BLP603654S, BLP603718S, BLP603760S, BLP603797S, BLP603805S, BLP603708S, BLP603615S, BLP603616S, BLP603617S, BLP603618S, BLP603614S, BLP603608S, BLP603609S, BLP603610S, BLP603611S, BLP603612S, BLP603731S, BLP603737S, BLP603738S, BLP603743S, BLP603744S, BLP603745S, BLP603746S, BLP603749S, BLP603750S, BLP603751S, BLP603752S, BLP603570S; GTIN 00643169980150, Lot Serial Numbers: BLP603685S, BLP603811S, BLP603812S, BLP603911S, BLP603949S, BLP603950S, BLP603951S, BLP603952S, BLP603958S, BLP603846S, BLP603862S, BLP603815S, BLP603816S, BLP603838S, BLP603863S, BLP603865S, BLP603953S, BLP604008S, BLP604022S, BLP604036S, BLP604051S, BLP604060S, BLP604065S, BLP604067S, BLP604091S, BLP604101S, BLP604102S, BLP604110S, BLP604113S, BLP604115S, BLP604119S, BLP604144S, BLP604145S, BLP604148S, BLP604155S, BLP604156S, BLP604173S, BLP604114S, BLP603954S, BLP603956S, BLP604019S, BLP604028S, BLP604002S, BLP604003S, BLP604004S, BLP604005S, BLP604007S, BLP604014S, BLP604015S, BLP604030S, BLP604034S, BLP604035S, BLP604037S, BLP604039S, BLP604041S, BLP604042S, BLP604043S, BLP604044S, BLP604045S, BLP604047S, BLP604048S, BLP604052S, BLP604053S, BLP604055S, BLP604056S, BLP604058S, BLP604059S, BLP604062S, BLP604066S, BLP604068S, BLP604069S, BLP604070S, BLP604071S, BLP604073S, BLP604074S, BLP604075S, BLP604076S, BLP604077S, BLP604081S, BLP604082S, BLP604085S, BLP604086S, BLP604088S, BLP604089S, BLP604090S, BLP604094S, BLP604095S, BLP604096S, BLP604097S, BLP604098S, BLP604104S, BLP604116S, BLP604117S, BLP604118S, BLP604120S, BLP604121S, BLP604122S, BLP604123S, BLP604124S, BLP604125S, BLP604126S, BLP604128S, BLP604129S, BLP604130S, BLP604131S, BLP604132S, BLP604134S, BLP604135S, BLP604136S, BLP604137S, BLP604138S, BLP604139S, BLP604140S, BLP604141S, BLP604142S, BLP604143S, BLP604158S, BLP604159S, BLP604160S, BLP604161S, BLP604162S, BLP604010S, BLP604012S, BLP604021S, BLP604026S, BLP604107S, BLP604108S, BLP604109S, BLP604040S, BLP604147S, BLP603566S, BLP603567S, BLP603679S, BLP603680S, BLP603720S, BLP603686S, BLP603723S, BLP603810S, BLP603915S, BLP603568S, BLP603682S, BLP603683S, BLP603688S, BLP603719S, BLP603814S, BLP603888S, BLP604000S, BLP604001S, BLP604079S, BLP604146S, BLP604027S, BLP604032S, BLP604033S, BLP604054S, BLP604057S, BLP603721S, BLP603722S, BLP603818S, BLP603819S, BLP603820S, BLP603821S, BLP603822S, BLP603823S, BLP603824S, BLP603825S, BLP603826S, BLP603828S, BLP603829S, BLP603830S, BLP603832S, BLP603833S, BLP603834S, BLP603835S, BLP603836S, BLP603837S, BLP603933S, BLP603934S, BLP603936S, BLP603939S, BLP603942S, BLP603944S, BLP603945S, BLP603946S, BLP603947S, BLP603948S, BLP604063S, BLP604064S, BLP604072S, BLP604168S, BLP604172S, BLP603882S, BLP603889S, BLP603893S, BLP603908S, BLP603912S, BLP603927S, BLP603887S, BLP603891S, BLP603892S, BLP603894S, BLP603898S, BLP603940S, BLP603941S, BLP603965S, BLP603989S, BLP603995S, BLP603997S, BLP604038S, BLP603883S, BLP603890S, BLP603897S, BLP603938S, BLP603980S, BLP603981S, BLP603982S, BLP603983S, BLP604013S, BLP604017S, BLP604023S, BLP604025S, BLP604078S, BLP604100S, BLP604165S, BLP604020S, BLP603902S, BLP603907S, BLP603993S, BLP603994S, BLP603895S, BLP603896S, BLP603935S, BLP603943S, BLP603979S, BLP603879S, BLP603880S, BLP603881S, BLP603885S, BLP603886S, BLP603899S, BLP603901S, BLP603903S, BLP603905S, BLP603916S, BLP603926S, BLP603930S, BLP603937S, BLP603973S, BLP603984S, BLP603992S, BLP603998S, BLP604011S, BLP604018S, BLP604024S, BLP604029S, BLP604031S, BLP604046S, BLP604049S, BLP604093S, BLP604099S, BLP604103S, BLP604112S, BLP604127S, BLP604133S, BLP604163S, BLP604164S, BLP604166S, BLP604016S, BLP604050S, BLP604061S, BLP604105S, BLP603840S, BLP603842S, BLP604157S, BLP603864S, BLP603866S, BLP603867S, BLP603860S, BLP603849S, BLP603850S, BLP603859S, BLP603861S, BLP604080S, BLP604092S, BLP604111S, BLP604167S, BLP604171S, BLP604174S, BLP604169S; GTIN 00763000612306, Lot Serial Numbers: BLP604149S, BLP604151S, BLP604176S, BLP604196S, BLP604150S, BLP604175S, BLP604177S, BLP604178S, BLP604179S, BLP604180S, BLP604181S, BLP604182S, BLP604183S, BLP604184S, BLP604185S, BLP604186S, BLP604187S, BLP604188S, BLP604189S, BLP604190S, BLP604191S, BLP604192S
- Product
- CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 523 units
- Distribution
- US Nationwide - Worldwide Distribution
- Recall date
- June 28, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)