Reported Jul 14, 2021 · Ongoing
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Medtronic Heart Valves Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Heart Valves Division · 1851 E Deere Ave · Santa Ana, CA · 92705-5720
Is this the product you have?
- CoreValve Evolut PRO Delivery Catheter System
- REF
ENVPRO-14ENVPRO-16
- Lot codes and dates
- Model Number/DescriptionENVPRO-14-US/18FR
- DELIV SYS ENVPRO-14-US GTIN00643169987203
- Lot Numbers
000967969000096886510009690887000969314200097165700009718679000972471500097351120009747816000974781700097697160009780304000978031200098136750009819798000983318600098331870009835584000988474300099035760009909651000991187800099167600009674373
- Model Number/DescriptionENVPRO-14/18FR
- DELIV SYS ENVPRO-14 GTIN
209 of 209 codes
00643169987258 Lot Numbers 000967437300096770410009681843000968657200096969430009702501000970831400097207070009730833000973286400097351110009741277000974528200097515370009751539000975392800097539300009759086000976357100097657040009765705000976979600097717810009778377000978030600097803150009797642000980162900098016320009815902000981590400098197950009824816000982717800098271800009831363000983136400098397370009843479000984625900098723990009872400000987523000098771650009879171000988276200098827640009885245000988837300098944680009894469000989624800098998160009902780000990357700099054760009907434000991675800099244410009930619
- Model Number/DescriptionENVPRO-16-US/20FR
- DELIV SYS ENVPRO-16-US GTIN00643169987210
- Lot Numbers
79 of 79 codes
000967437200096770400009679689000968184200096886490009688650000968865200096931400009693141000969314300097005070009702502000970831300097103300009716568000971656900097165710009718678000972241700097224180009724713000972471400097290710009730831000973286100097328630009737234000973723500097412760009743440000975153800097515400009753926000975392900097590850009771780000977418000097783760009780303000978030800097803110009780314000978869700097886980009801633000981056900098105700009811909000981367800098198000009821182000982285500098236560009829625000983319000098375050009839738000983973900098397400009845304
- Model Number/DescriptionENVPRO-16-C/20FR
- DELIV SYS ENVPRO-16-C GTIN00643169987319
- Lot Numbers
00096969410009738986000977177900098035830009863079
- Model Number/DescriptionENVPRO-16/20FR
- DELIV SYS ENVPRO-16 GTIN00643169987265
- Lot Numbers
281 of 281 codes
000967437100096770380009679691000967969200096843270009686569000968657000096865710009696942000969869700097025000009702503000970831200097103310009730832000973286200097372360009738987000974127800097434390009745281000974781400097478150009753924000975392700097582190009759084000975908700097633740009763376000977417900097783750009780302000978030500097803070009780310000978869400097886960009788699000978870000097952970009795298000979529900097976430009801628000980163100098057240009808236000981190800098136760009813677000981590300098159050009819799000982365400098236550009827179000982936900098293700009829624
- Amount recalled
- Total of all Delivery Systems (Globally) = 67,339 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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