CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Summary
The FDA issued a Class II for CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16; by Medtronic Heart Valves Division. Reason: Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020..
Details
Source
Device Recall
External ID
Z-2042-2021
Action Date
2021-07-14
Status
Ongoing
Category
device
Product Description
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Lot/Code Info: 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;
Quantity Affected: Total of all Delivery Systems (Globally) = 67,339 units
Reason for Recall
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Distribution
U.S.: AL, AK, AR, AZ, CA, CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Albania, Argentina, Australia, Austria, Belarus, Belgium, Brazil, BULGARIA, Canada, Chile, CHINA, Colombia, COSTA RICA, Croatia, Curacao, CYPRUS, Czech Republic, Denmark, DOMINICAN REPUBLIC, Egypt, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, Germany, Greece, GUATEMALA, HONDURAS, Hong Kong, Hungary, ICELAND, India, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), Ireland, Israel, Italy, Japan, JORDAN, KAZAKHSTAN, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LITHUANIA, Luxembourg, MACEDONIA (THE FORMER YUGOSLAV REPUBLIC OF), Malaysia, MALTA, Mexico, MOLDOVA (REPUBLIC OF), Montenegro, Netherlands, New Zealand, Norway, OMAN, Panama, Peru, Poland, Portugal, QATAR, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, SLOVAKIA (Slovak Republic), SLOVENIA, South Africa, Spain, Sweden, Switzerland, SYRIAN ARAB REPUBLIC, Taiwan (Republic of China), THAILAND, Turkey, UNITED ARAB EMIRATES, United Kingdom, URUGUAY, UZBEKISTAN, VENEZUELA and Viet Nam.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-11
Company
Santa Ana, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Heart Valves Division has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Heart Valves Division) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Heart Valves Division have FDA actions?
Medtronic Heart Valves Division has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2042-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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