Medtronic Heart Valves Division CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16; Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Brand
Medtronic Heart Valves Division
Lot Codes / Batch Numbers
0009688651, 0009690887, 0009693142, 0009716570, 0009718679, 0009724715, 0009735112, 0009747816, 0009747817, 0009769716, 0009780304, 0009780312, 0009813675, 0009819798, 0009833186, 0009833187, 0009835584, 0009884743, 0009903576, 0009909651, 0009911878, 0009916760, 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, 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, 0009738986, 0009771779, 0009803583, 0009863079, 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
Products Sold
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;
Medtronic Heart Valves Division is recalling CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16; due to Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Recommended Action
Per FDA guidance
On 06/09/2021, the Recalling Firm sent an "URGENT MEDICAL DEVICE RECALL" Notification via UPS 2-day (US Customers) and regionally approved methods (OUS Customer) to customers informing them that it has been identified that were is the potential for actuator separation with delivery catheter systems manufactured before 07/11/2020. Customer are instructed to: 1. Identify and quarantine all unused affected product manufactured before 11-JUL-2020.The enclosed Customer Notification Detail Report includes affected product for their facility. 2. Return all unused affected product in their inventory to Recalling Firm. Contact Customer Service at 800-854-3570 to initiate a product return. Their local Representative can assist them as necessary in initiating the return of this product. 3. Complete the enclosed Customer Confirmation Form and email it to rs.cfqfca@medtronic.com. 4. Forward this notice to all who need to be aware within their organization and to any organization where the affected product may have been transferred. For any questions or assistance, contact Customer Service at 800-854-3570
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, DC, PR
Page updated: Jan 10, 2026