Use caution Medical device recall · FDA · Published June 11, 2021

Medtronic CoreValve Evolut PRO Delivery Catheter Recall: Actuator Separation Risk

Medtronic recalls CoreValve Evolut PRO Delivery Catheter Systems (manufactured before July 11, 2020) due to reported actuator separation. Affected units include specific model numbers and lot numbers listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2042-2021Medical device Medtronic ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmMedtronic Heart Valves Division1851 E Deere Ave · Santa Ana, CA 92705-5720

✎ GovInfoNow plain-language explainer

Medtronic is recalling certain CoreValve Evolut PRO Delivery Catheter Systems made before July 11, 2020 because of reports of actuator separation. This could lead to improper function of the device during medical procedures. Read more at govinfonow.com/recall/62348-medtronic-corevalve-evolut-pro-delivery-catheter-recall-actuator-separation-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62348-medtronic-corevalve-evolut-pro-delivery-catheter-recall-actuator-separation-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2042-2021

Cite this page

“Medtronic CoreValve Evolut PRO Delivery Catheter Recall: Actuator Separation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62348-medtronic-corevalve-evolut-pro-delivery-catheter-recall-actuator-separation-risk. Based on FDA recall #Z-2042-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2042-2021%22&limit=1).

The FDA announced on June 11, 2021, that Medtronic Heart Valves Division is recalling CoreValve Evolut PRO Delivery Catheter Systems due to reports of actuator separation. The agency classified the recall as Class II and ongoing.

How to tell if you have it

Brand: Medtronic
Product: CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16
GTIN/UPC: 00643169987203, 00643169987210, 00643169987258, 00643169987265, 00643169987319
Manufacture date: Before July 11, 2020

The hazard

The recall addresses reports of actuator separation for various delivery catheter systems. The affected products were manufactured before July 11, 2020.

Context

GovInfoNow's records show Medtronic Heart Valves Division has two other recalls on record since October 23, 2020. On May 22, 2026, the company recalled the Harmony Catheter System due to a risk of tip detachment during procedures. Other recent recalls of similar products include the Medtronic DLP Retrograde Cannula Recall (April 21, 2026) and Medline Medical Procedure Kits Recalls (May 4, 2026).

How to tell if you have this one

Check for model numbers ENVPRO-14, ENVPRO-16, or ENVPRO-16-C with specific lot numbers listed in the recall notice. Products manufactured before July 11, 2020 are affected.

Brand
Medtronic
Product
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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.

Recall number	Product, codes & lots
Z-2041-2021	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;
Z-2042-2021	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;
Z-2043-2021	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;

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify your catheter system model and lot numbers to determine if it is affected by this recall.
Contact Medtronic
Reach out to Medtronic directly for guidance on next steps if your product is affected.

Where it went and when

Where it was distributed

Distributed in 46 states and D.C. and Puerto Rico, and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 33 days after the firm started it.

Jun 11, 2021Firm started the recall
Jul 8, 2021FDA classified it Class II
Jul 14, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62348-medtronic-corevalve-evolut-pro-delivery-catheter-recall-actuator-separation-risk">Medtronic CoreValve Evolut PRO Delivery Catheter Recall: Actuator Separation Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2042-2021 (June 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2042-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.