Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.
Reason for recall: Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention. Distribution: Domestic US Nationwide distribution including Puerto Rico. International distribution worldwide. Quantity: 26,570 (1,333 US; 25,174 OUS) Lot/code info: 1. H7493915010240 UDI-DI 08714729781097 Batches 35277608 35315983 35315984 35315985 35380314 35452835 35452836 35514614 35551688 35551689 35664523 35664524 35750157 35750158 35750159 35750400 35879409 35879410 35921915 35922951 35926817 35926818 35942366 36056965 36058841 36058842 36058843 36096638 36121883 36138618 36138619 36138801 36138802 36138803 36159671 36195057 36195058 36195059 36195360 36205167 36209423 36214805 36214806 36256192 36322725 36348207 36348208 36348209 36498256 36588496 36607566 36711321; 2. H7493915010310 UDI-DI 08714729781110 Batches 35294379 35294540 35295922 35330503 35330504 35336132 35347263 35382292 35383351 35383352 35453002 35461487 35461488 35528579 35529200 35628964 35628965 35628966 35641995 35662047 35664484 35664485 35750401 35750402 35750403 35750404 35750405 35750406 35750407 35890012 35893584 35893585 35894358 35894359 35938922 35938923 35938924 35938925 35938926 36002641 36002642 36063291 36063292 36105446 36133161 36134808 36144148 36148535 36154091 36154092 36154093 36154094 36154095 36169871 36169872 36197809 36197810 36197811 36197812 36197813 36200118 36202762 36204350 36212466 36212467 36212468 36256193 36256194 36256195 36357711 36357712 36368143 36368144 36368145 36516036 36603362 36603363 36642784 36683543 36688775 36811476 36811477 36818953; 3. H749391506220 UDI-DI 08714729781158 Batches 35582211 35750408 35947814 35947815 35950476 36009906 36292862 36397124 36652844; 4. H749391508210 UDI-DI 08714729781172 Batches 35343574 35
08714729781097, 08714729781110, 08714729781158, 08714729781172, 08714729781196, 08714729263869, 08714729263876, 08714729263883, 08714729263890, 08714729263906, 08714729263913, 08714729263920, 08714729781165, 08714729781189, 08714729781202, 08714729781226, 08714729781103, 08714729781127, 08714729781141
Official record: FDA (Device enforcement) ↗
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