Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 92328
Description: ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 92328 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1708-2023 |
| Event ID | 92328 |
| Event Description | ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators |
| Product Type | Devices |
| Distribution | US Nationwide - Worldwide Distribution |
| Quantity | 727 units |
| Recall Reason | 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. |
| Device Classification | 20230628 |
| Device Code Info | GTIN 00643169217928, Lot Serial Numbers: BWD609356S, BWD609450S, BWD609318S, BWD609387S, BWD609454S, BWD609558S, BWD609464S, BWD609549S, BWD609355S, BWD609467S, BWD609389S, BWD609343S, BWD609397S, BWD609567S, BWD609395S, BWD609462S, BWD609470S, BWD609316S, BWD609554S, BWD609551S, BWD609594S, BWD609391S, BWD609466S, BWD609560S, BWD609473S, BWD609288S, BWD609322S, BWD609352S, BWD609360S, BWD609465S, BWD609476S, BWD609547S, BWD609363S, BWD609472S, BWD609573S, BWD609319S, BWD609526S, BWD609570S, BWD609448S, BWD609370S, BWD609320S, BWD609367S, BWD609317S, BWD609368S, BWD609371S, BWD609385S, BWD609362S, BWD609373S, BWD609381S, BWD609346S, BWD609574S, BWD609572S, BWD609365S, BWD609357S, BWD609348S, BWD609451S, BWD609568S, BWD609386S, BWD609344S, BWD609468S, BWD609559S, BWD609569S, BWD609342S, BWD609347S, BWD609353S, BWD609566S, BWD609374S, BWD609453S, BWD609361S, BWD609459S, BWD609460S, BWD609392S, BWD609553S, BWD609562S, BWD609359S, BWD609345S, BWD609366S, BWD609384S, BWD609455S, BWD609399S, BWD609354S, BWD609461S, BWD609403S, BWD609388S, BWD609321S, BWD609458S, BWD609351S, BWD609545S; GTIN 00643169969551, Lot Serial Numbers: BWD609418S, BWD609419S, BWD609420S, BWD609421S, BWD609422S, BWD609423S, BWD609424S, BWD609425S, BWD609426S, BWD609427S, BWD609428S, BWD609429S, BWD609430S, BWD609431S, BWD609432S, BWD609433S, BWD609434S, BWD609435S, BWD609437S, BWD609438S, BWD609439S, BWD609440S, BWD609441S, BWD609442S, BWD609443S, BWD609471S, BWD609331S, BWD609315S, BWD609295S, BWD609313S, BWD609576S, BWD609690S, BWD609323S, BWD609222S, BWD609587S, BWD609492S, BWD609520S, BWD609328S, BWD609407S, BWD609408S, BWD609513S, BWD609609S, BWD609625S, BWD609404S, BWD609332S, BWD609563S, BWD609602S, BWD609605S, BWD609475S, BWD609483S, BWD609484S, BWD609564S, BWD609565S, BWD609495S, BWD609510S, BWD609519S, BWD609536S, BWD609584S, BWD609598S, BWD609762S, BWD609899S, BWD609224S, BWD609303S, BWD609377S, BWD609400S, BWD609449S, BWD609502S, BWD609542S, BWD609543S, BWD609597S, BWD609378S, BWD609523S, BWD609534S, BWD609535S, BWD609541S, BWD609575S, BWD609579S, BWD609590S, BWD609593S, BWD609629S, BWD609682S, BWD609788S, BWD609792S, BWD609839S, BWD609901S, BWD609905S, BWD609908S, BWD609600S, BWD609604S, BWD609630S, BWD609632S, BWD609635S, BWD609636S, BWD609638S, BWD609687S, BWD609688S, BWD609689S, BWD609280S, BWD609284S, BWD609285S, BWD609286S, BWD609287S, BWD609298S, BWD609306S, BWD609307S, BWD609312S, BWD609314S, BWD609339S, BWD609369S, BWD609375S, BWD609376S, BWD609413S, BWD609414S, BWD609489S, BWD609491S, BWD609493S, BWD609494S, BWD609504S, BWD609505S, BWD609506S, BWD609507S, BWD609508S, BWD609517S, BWD609521S, BWD609538S, BWD609540S, BWD609546S, BWD609548S, BWD609550S, BWD609561S, BWD609585S, BWD609586S, BWD609589S, BWD609643S, BWD609835S, BWD609836S, BWD609299S, BWD609539S, BWD609552S, BWD609578S, BWD609582S, BWD609599S, BWD609681S, BWD609686S, BWD609895S, BWD609904S, BWD609909S, BWD609415S, BWD609416S, BWD609417S, BWD609525S, BWD609529S, BWD609680S, BWD609537S, BWD609275S, BWD609276S, BWD609277S, BWD609278S, BWD609514S, BWD609639S, BWD609640S, BWD609644S, BWD609757S, BWD609296S, BWD609297S, BWD609300S, BWD609301S, BWD609530S, BWD609531S, BWD609533S, BWD609341S, BWD609336S, BWD609338S, BWD609340S, BWD609524S, BWD609704S, BWD609706S, BWD609756S, BWD609760S, BWD609790S, BWD609791S, BWD609955S, BWD609956S, BWD609957S, BWD609958S, BWD609959S, BWD609960S, BWD609963S, BWD609290S, BWD609292S, BWD609293S, BWD609283S, BWD609333S, BWD609436S, BWD609518S, BWD609592S, BWD609628S, BWD609291S, BWD609294S, BWD609302S, BWD609763S, BWD609785S, BWD609793S, BWD609894S, BWD609896S, BWD609906S, BWD609580S, BWD609496S, BWD609308S, BWD609583S, BWD609631S, BWD609309S, BWD609498S, BWD609786S, BWD609903S, BWD609910S, BWD609325S, BWD609326S, BWD609501S, BWD609596S, BWD609603S, BWD609305S, BWD609452S, BWD609463S, BWD609481S, BWD609705S, BWD609707S, BWD609708S, BWD609709S, BWD609710S, BWD609711S, BWD609712S, BWD609713S, BWD609755S, BWD609758S, BWD609383S, BWD609509S, BWD609571S, BWD609581S, BWD609223S, BWD609380S, BWD609382S, BWD609327S, BWD609480S, BWD609482S, BWD609488S, BWD609490S, BWD609499S, BWD609500S, BWD609511S, BWD609512S, BWD609606S, BWD609607S, BWD609787S, BWD609642S, BWD609289S, BWD609329S, BWD609946S, BWD609947S, BWD609948S, BWD609949S, BWD609951S, BWD609952S, BWD609944S, BWD609950S, BWD609961S, BWD609962S, BWD609945S, BWD609953S; GTIN 00643169980211, Lot Serial Numbers: BWD609982S, BWD609997S, BWD610057S, BWD610087S, BWD609770S, BWD609970S, BWD609798S, BWD609875S, BWD609877S, BWD610151S, BWD609889S, BWD610004S, BWD610036S, BWD609623S, BWD609991S, BWD610045S, BWD610051S, BWD610052S, BWD610040S, BWD610041S, BWD609800S, BWD609650S, BWD609702S, BWD609741S, BWD610097S, BWD610199S, BWD610061S, BWD609646S, BWD610058S, BWD610142S, BWD610143S, BWD610144S, BWD610145S, BWD610149S, BWD610150S, BWD610157S, BWD610161S, BWD610197S, BWD610205S, BWD610206S, BWD610207S, BWD610208S, BWD610210S, BWD610211S, BWD610212S, BWD610213S, BWD610214S, BWD610216S, BWD610226S, BWD610227S, BWD610228S, BWD610229S, BWD610259S, BWD610265S, BWD610134S, BWD610141S, BWD609647S, BWD610133S, BWD610148S, BWD610158S, BWD610160S, BWD610215S, BWD610262S, BWD610055S, BWD610056S, BWD610135S, BWD610137S, BWD609672S, BWD609724S, BWD609721S, BWD610098S, BWD610164S, BWD610200S, BWD609648S, BWD609649S, BWD609651S, BWD609652S, BWD609719S, BWD609720S, BWD609694S, BWD609729S, BWD609732S, BWD609740S, BWD609747S, BWD609751S, BWD609817S, BWD609824S, BWD609825S, BWD609827S, BWD609845S, BWD609850S, BWD609851S, BWD609852S, BWD609853S, BWD609860S, BWD609863S, BWD609874S, BWD609876S, BWD609881S, BWD609882S, BWD609883S, BWD609884S, BWD609885S, BWD609886S, BWD609891S, BWD609892S, BWD609893S, BWD609976S, BWD609990S, BWD610005S, BWD610007S, BWD610009S, BWD610010S, BWD610013S, BWD610021S, BWD610032S, BWD610076S, BWD610077S, BWD610078S, BWD610079S, BWD610082S, BWD610085S, BWD610127S, BWD610162S, BWD610122S, BWD610218S, BWD610219S, BWD610220S, BWD610222S, BWD610223S, BWD610224S, BWD610251S, BWD610254S, BWD610255S, BWD610257S, BWD609971S, BWD609979S, BWD610022S, BWD610059S, BWD610196S, BWD610065S, BWD610070S, BWD610074S, BWD610075S, BWD610118S, BWD610120S, BWD610128S, BWD610180S, BWD610258S, BWD610260S, BWD609924S, BWD610071S, BWD610073S, BWD610168S, BWD610169S, BWD610170S, BWD610171S, BWD610174S, BWD610238S, BWD610240S, BWD610204S, BWD610108S, BWD610113S, BWD610139S, BWD610049S, BWD609862S, BWD609967S, BWD609968S, BWD609969S, BWD609972S, BWD609973S, BWD609974S, BWD609980S, BWD609983S, BWD609992S, BWD609994S, BWD609995S, BWD610039S, BWD610044S, BWD610012S, BWD609890S, BWD609925S, BWD610080S, BWD610155S, BWD610119S, BWD610146S, BWD609769S, BWD610072S, BWD610121S, BWD610159S, BWD610261S, BWD609737S, BWD609738S, BWD609739S, BWD609978S, BWD609986S, BWD610053S, BWD609744S, BWD609749S, BWD609844S, BWD609856S, BWD609857S, BWD609879S, BWD609887S, BWD610062S, BWD609797S, BWD609989S, BWD609993S, BWD610006S, BWD610030S, BWD610037S, BWD610054S, BWD610067S, BWD610138S, BWD610066S, BWD610069S, BWD610217S, BWD609815S, BWD609816S, BWD609831S, BWD609833S, BWD609745S, BWD610060S, BWD610125S, BWD610124S, BWD610131S, BWD609932S, BWD609768S, BWD609753S, BWD609846S, BWD609847S, BWD609767S, BWD609804S, BWD609805S, BWD609818S, BWD609819S, BWD609820S, BWD609821S, BWD609822S, BWD609823S, BWD609826S, BWD609828S, BWD609829S, BWD609830S, BWD609832S, BWD609848S, BWD609849S, BWD609854S, BWD609855S, BWD609858S, BWD609859S, BWD609861S, BWD609444S, BWD609446S, BWD609615S, BWD609616S, BWD609617S, BWD609618S, BWD609619S, BWD609620S, BWD609621S, BWD609622S, BWD609624S, BWD609653S, BWD609655S, BWD609656S, BWD609657S, BWD609658S, BWD609659S, BWD609660S, BWD609661S, BWD609662S, BWD609663S, BWD609664S, BWD609665S, BWD609669S, BWD609670S, BWD609671S, BWD609673S, BWD609674S, BWD609676S, BWD609678S, BWD609679S, BWD609691S, BWD609736S, BWD609743S, BWD609748S, BWD609878S, BWD610047S, BWD610048S, BWD610003S, BWD609654S, BWD609666S, BWD609667S, BWD609668S, BWD609675S, BWD609692S, BWD609693S, BWD609695S, BWD609696S, BWD609697S, BWD609700S, BWD609701S, BWD609714S, BWD609715S, BWD609717S, BWD609730S, BWD609731S, BWD609733S, BWD609734S, BWD609735S, BWD609928S, BWD610046S, BWD610015S, BWD610018S, BWD610019S, BWD610024S, BWD610083S, BWD610090S, BWD609964S, BWD609965S, BWD609966S, BWD609975S, BWD609977S, BWD609996S, BWD609998S, BWD609999S, BWD610000S, BWD610001S, BWD610002S, BWD610014S, BWD610016S, BWD610011S, BWD610017S, BWD610023S, BWD610086S, BWD610092S, BWD610096S, BWD610099S, BWD610101S, BWD610102S, BWD610106S, BWD610107S, BWD610111S, BWD610209S, BWD610221S, BWD610230S, BWD610147S, BWD610126S, BWD610130S, BWD610115S, BWD610116S, BWD610117S, BWD610123S, BWD610093S, BWD610203S, BWD610233S, BWD610235S, BWD610237S, BWD610239S, BWD610242S, BWD610252S, BWD610253S, BWD610256S, BWD610264S, BWD610268S, BWD610272S, BWD610234S; GTIN 00763000612085, Lot Serial Numbers: BWD610291S, BWD610248S |
| Center Classification Date | 20230616 |
| Recall Initiation Date | 20230510 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Letter |
| Similar To |