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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Medtronic Heart Valves Division: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.

Agency Publication Date: July 9, 2021
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Affected Products

Product: CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;

Model Number/Description: ENVEOR-L/DELIV SYS EnVeoR-L OREVAC 18Fr GTIN: 00643169800922 Lot Numbers: 0010199879; 0010204030; 0010209069; 0010209070; 0010279048; 0010281657; 0010289860; 0010296299; Model Number/Description: ENVEOR-N/DELIV SYS EnVeoR-N OREVAC 20Fr GTIN: 00643169800946 Lot Numbers 0010199873; 0010199874; 0010209064; 0010211942; 0010253924; 0010258778; 0010260161; 0010262936; 0010289861; 0010296302; 0010297110; 0010301887;

Lot Numbers:
Numbers
Numbers
Product: CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;

Model Number/Description: ENVPRO-14-US/18FR DELIV SYS ENVPRO-14-US GTIN:00643169987203 Lot Numbers: 0009679690; 0009688651; 0009690887; 0009693142; 0009716570; 0009718679; 0009724715; 0009735112; 0009747816; 0009747817; 0009769716; 0009780304; 0009780312; 0009813675; 0009819798; 0009833186; 0009833187; 0009835584; 0009884743; 0009903576; 0009909651; 0009911878; 0009916760; 0009674373; Model Number/Description: ENVPRO-14/18FR DELIV SYS ENVPRO-14 GTIN: 00643169987258 Lot Numbers 0009674373; 0009677041; 0009681843; 0009686572; 0009696943; 0009702501; 0009708314; 0009720707; 0009730833; 0009732864; 0009735111; 0009741277; 0009745282; 0009751537; 0009751539; 0009753928; 0009753930; 0009759086; 0009763571; 0009765704; 0009765705; 0009769796; 0009771781; 0009778377; 0009780306; 0009780315; 0009797642; 0009801629; 0009801632; 0009815902; 0009815904; 0009819795; 0009824816; 0009827178; 0009827180; 0009831363; 0009831364; 0009839737; 0009843479; 0009846259; 0009872399; 0009872400; 0009875230; 0009877165; 0009879171; 0009882762; 0009882764; 0009885245; 0009888373; 0009894468; 0009894469; 0009896248; 0009899816; 0009902780; 0009903577; 0009905476; 0009907434; 0009916758; 0009924441; 0009930619; 0009930620; 0009932436; 0009935871; 0009940329; 0009941896; 0009943765; 0009943766; 0009950526; 0009956449; 0009959205; 0009959208; 0009968628; 0009971361; 0009973690; 0009974884; 0009974886; 0009979351; 0009981603; 0009981605; 0009992252; 0009992254; 0009999409; 0010001291; 0010004099; 0010004100; 0010007364; 0010007368; 0010010945; 0010014267; 0010017314; 0010017315; 0010021500; 0010021501; 0010024637; 0010026718; 0010028933; 0010030671; 0010032826; 0010032828; 0010037869; 0010037870; 0010037876; 0010040826; 0010040828; 0010044464; 0010044465; 0010051010; 0010051348; 0010054636; 0010058015; 0010061411; 0010061412; 0010063249; 0010063250; 0010081656; 0010083965; 0010087639; 0010091721; 0010091723; 0010097384; 0010097385; 0010099753; 0010099756; 0010100832; 0010100833; 0010100834; 0010100835; 0010105882; 0010105884; 0010108127; 0010108133; 0010108134; 0010108135; 0010120343; 0010124203; 0010126036; 0010129931; 0010131801; 0010133987; 0010136245; 0010136247; 0010139633; 0010139634; 0010143248; 0010143249; 0010143251; 0010145133; 0010148991; 0010153126; 0010153127; 0010153129; 0010157415; 0010161319; 0010163782; 0010169460; 0010169463; 0010169465; 0010175290; 0010175291; 0010175292; 0010184723; 0010184724; 0010184725; 0010188540; 0010194379; 0010194380; 0010197789; 0010199885; 0010204027; 0010209066; 0010211940; 0010211941; 0010220455; 0010245329; 0010248119; 0010249598; 0010252313; 0010253923; 0010255302; 0010256429; 0010256431; 0010257814; 0010258779; 0010260159; 0010261391; 0010262934; 0010268205; 0010268207; 0010269513; 0010271607; 0010273066; 0010273067; 0010275572; 0010275573; 0010278032; 0010278033; 0010281654; 0010282945; 0010285882; 0010285884; 0010286952; 0010286953; 0010288572; 0010288573; 0010288575; 0010289863; 0010297581; 0010297582; 0010301885; Model Number/Description: ENVPRO-16-US/20FR DELIV SYS ENVPRO-16-US GTIN:00643169987210 Lot Numbers: 0009674372; 0009677040; 0009679689; 0009681842; 0009688649; 0009688650; 0009688652; 0009693140; 0009693141; 0009693143; 0009700507; 0009702502; 0009708313; 0009710330; 0009716568; 0009716569; 0009716571; 0009718678; 0009722417; 0009722418; 0009724713; 0009724714; 0009729071; 0009730831; 0009732861; 0009732863; 0009737234; 0009737235; 0009741276; 0009743440; 0009751538; 0009751540; 0009753926; 0009753929; 0009759085; 0009771780; 0009774180; 0009778376; 0009780303; 0009780308; 0009780311; 0009780314; 0009788697; 0009788698; 0009801633; 0009810569; 0009810570; 0009811909; 0009813678; 0009819800; 0009821182; 0009822855; 0009823656; 0009829625; 0009833190; 0009837505; 0009839738; 0009839739; 0009839740; 0009845304; 0009867880; 0009867881; 0009872402; 0009877163; 0009879660; 0009880134; 0009909647; 0009909649; 0009914677; 0009916004; 0009916759; 0009916762; 0009916764; 0009922784; 0009981601; 0010041604; 0010148988; 0010172263; 0010172264; Model Number/Description: ENVPRO-16-C/20FR DELIV SYS ENVPRO-16-C GTIN:00643169987319 Lot Numbers: 0009696941; 0009738986; 0009771779; 0009803583; 0009863079; Model Number/Description: ENVPRO-16/20FR DELIV SYS ENVPRO-16 GTIN:00643169987265 Lot Numbers: 0009674371; 0009677038; 0009679691; 0009679692; 0009684327; 0009686569; 0009686570; 0009686571; 0009696942; 0009698697; 0009702500; 0009702503; 0009708312; 0009710331; 0009730832; 0009732862; 0009737236; 0009738987; 0009741278; 0009743439; 0009745281; 0009747814; 0009747815; 0009753924; 0009753927; 0009758219; 0009759084; 0009759087; 0009763374; 0009763376; 0009774179; 0009778375; 0009780302; 0009780305; 0009780307; 0009780310; 0009788694; 0009788696; 0009788699; 0009788700; 0009795297; 0009795298; 0009795299; 0009797643; 0009801628; 0009801631; 0009805724; 0009808236; 0009811908; 0009813676; 0009813677; 0009815903; 0009815905; 0009819799; 0009823654; 0009823655; 0009827179; 0009829369; 0009829370; 0009829624; 0009831669; 0009833189; 0009837504; 0009880131; 0009880135; 0009898071; 0009898072; 0009903578; 0009909648; 0009909650; 0009911877; 0009916005; 0009916761; 0009916763; 0009922783; 0009924443; 0009926465; 0009926466; 0009930616; 0009930617; 0009935878; 0009946124; 0009948223; 0009950524; 0009950527; 0009953807; 0009953808; 0009956448; 0009959204; 0009959206; 0009959207; 0009959209; 0009965514; 0009968626; 0009968627; 0009968629; 0009971360; 0009971362; 0009971364; 0009973689; 0009973693; 0009973694; 0009979348; 0009981602; 0009981604; 0009989097; 0009989098; 0009992249; 0009992251; 0009994564; 0009994566; 0009999410; 0009999411; 0010001292; 0010004101; 0010007363; 0010007367; 0010007370; 0010010943; 0010010944; 0010014262; 0010014263; 0010014265; 0010017316; 0010017317; 0010021502; 0010021503; 0010024639; 0010024640; 0010026719; 0010028932; 0010032824; 0010032827; 0010035760; 0010035761; 0010037867; 0010037868; 0010037871; 0010037872; 0010037877; 0010040827; 0010044462; 0010044463; 0010047949; 0010051008; 0010051009; 0010057224; 0010057225; 0010058013; 0010058014; 0010058019; 0010058020; 0010063248; 0010081654; 0010081655; 0010087625; 0010087642; 0010091719; 0010091720; 0010093573; 0010093574; 0010095465; 0010097381; 0010097383; 0010099752; 0010099755; 0010100831; 0010103512; 0010103515; 0010108121; 0010108128; 0010108137; 0010108139; 0010108142; 0010118094; 0010118095; 0010120341; 0010124201; 0010124205; 0010126032; 0010126035; 0010129929; 0010129932; 0010139636; 0010142028; 0010143246; 0010145130; 0010145132; 0010145135; 0010148989; 0010153121; 0010157412; 0010161314; 0010161315; 0010163780; 0010163781; 0010163783; 0010163784; 0010171864; 0010171865; 0010171867; 0010175289; 0010182732; 0010182734; 0010182737; 0010187014; 0010187015; 0010188539; 0010188542; 0010188543; 0010194378; 0010197791; 0010199875; 0010199876; 0010204026; 0010204028; 0010209063; 0010209065; 0010209067; 0010211939; 0010215734; 0010215735; 0010217153; 0010217154; 0010217155; 0010220453; 0010220454; 0010222008; 0010222010; 0010225045; 0010225046; 0010245327; 0010245328; 0010245330; 0010248117; 0010248118; 0010249599; 0010249600; 0010252314; 0010252315; 0010253925; 0010255303; 0010255304; 0010256430; 0010256432; 0010257815; 0010258780; 0010260160; 0010261392; 0010262935; 0010262937; 0010268206; 0010269510; 0010269511; 0010271608; 0010271609; 0010273068; 0010273069; 0010275574; 0010275575; 0010278034; 0010278035; 0010279049; 0010279052; 0010279053; 0010279934; 0010279935; 0010281655; 0010281656; 0010282946; 0010285883; 0010285885; 0010286955; 0010291594; 0010291596; 0010297111; 0010297583; 0010300584; 0010300585; 0010301886; 0010303396;

Lot Numbers:
Numbers
Numbers
Numbers
Numbers
Numbers
Product: CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;

Model Number/Description: D-EVPROP2329US/DELIV SYS D-EVPROP2329US GTIN:00763000207854 Lot Numbers: 0010165308; 0010165310; 0010165312; 0010165313; 0010169462; 0010169464; 0010171866; 0010171868; 0010171869; 0010173361; 0010175293; 0010175294; 0010181410; 0010181411; 0010181412; 0010182735; 0010182736; 0010188541; 0010192246; 0010192247; 0010197788; 0010197790; 0010199877; 0010199878; 0010199880; 0010204029; 0010216175; 0010216176; 0010222009; 0010222011; 0010225047; 0010271291; 0010271292; 0010271293; 0010273071; 0010279050; 0010279938; 0010288574; 0010289862; 0010291595; 0010291597; 0010294650; 0010294651; 0010294652; 0010296300; 0010296301; Model Number/Description:D-EVPROP34US/DELIV SYS D-EVPROP34US SA GTIN:00763000207861 Lot Numbers: 0010165309; 0010165311; 0010291593; 0010294653; 0010294654; 0010303395;

Lot Numbers:
Numbers
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88113
Status: Active
Manufacturer: Medtronic Heart Valves Division
Manufactured In: United States
Units Affected: 3 products (Total of all Delivery Systems (Globally) = 67,339 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.