{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Ongoing", "city": "Maple Grove", "state": "MN", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "78587", "recalling_firm": "Boston Scientific Corporation", "address_1": "2 Scimed Pl", "address_2": "N/A", "postal_code": "55311-1565", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution - US Nationwide Distributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed internationally to Canada", "recall_number": "Z-0686-2018", "product_description": "Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. a. H74939180051870 (Material Description Innova-EU 5 x 180 x 75); b. H74939180061870 (Material Description Innova-EU 6 x 180 x 75); c. H74939180071870 (Material Description Innova-EU 7 x 180 x 75); d. H74939180071870 (Material Description Innova-EU 8 x 180 x 75); e. H74939181051830 (Material Description Innova-EU 5 x 180 x 130); f. H74939181061830 (Material Description Innova-EU 6 x 180 x 130); g. H74939181071830 (Material Description Innova-EU 7 x 180 x 130); h. H74939181081830 (Material Description Innova-EU 8 x 180 x 130); i. H74939259051830 (Material Description Innova-China 5 x 180 x 130); j. H74939259061830 (Material Description Innova-China 6 x 180 x 130); k. H74939259071830 (Material Description Innova-China 7 x 180 x 130); l. H74939259081830 (Material Description Innova-China 8 x 180 x 130); m. H74939259081870 (Material Description Innova-China 8 x 180 x 75); n.H74939293051830 (Material Description Innova 5 x 180 x 130); o. H74939293051870 (Material Description Innova 5 x 180 x 75); p. H74939293061830 (Material Description Innova 6 x 180 x 130); q. H74939293061870 (Material Description Innova 6 x 180 x 75); r. H74939293071830 (Material Description Innova 7 x 180 x 130); s. H74939293071870 (Material Description Innova 7 x 180 x 75); t. H74939293081830 (Material Description Innova 8 x 180 x 130); u. H74939293081870 (Material Description Innova 8 x 180 x 75);", "product_quantity": "22,916 units total", "reason_for_recall": "Stent possibly unable to be fully released from the delivery system.", "recall_initiation_date": "20171106", "center_classification_date": "20180222", "report_date": "20180228", "code_info": "a. Innova-EU 5 x 180 x 75 (Batch No. 17520924 18202150 18759183 19079259 19699151 19699152 19699153 19699154 19741583 19750952 19856648 19858137 20818430); b. Innova-EU 6 x 180 x 75 (Batch No. 17620115 17692708 17855043 18018503 18061521 18074203 18202155 18255925 18353496 18412277 18478379 18751462 18920645 18931139 19021594 19342056 19394346 19426941 19644666 19741582 19946632 20197319 20495963 20818433 21239460 ); c. Innova-EU 7 x 180 x 75 (Batch No. 17612617 17832625 18082136 18394610 19750817 20314145); d. Innova-EU 8 x 180 x 75 (Batch No. 17520931 18628352 20818435); e. Innova-EU 5 x 180 x 130 (Batch No. 17379136 17515253 17643398 17796883 17884790 17928403 17999422 18028550 18065189 18193713 18242545 18320365 18412270 18505175 18572704 18754507 18924413 18937020 18945803 19048201 19129188 19264799 19406217 19469659 19654093 19728059 19770174 19858438 19907842 20042126 20109694 20127894 20205065 20260073 20313036 20405381 20427160 20482532 20557178 20642269 20788044 20980789 21091410 21153699 21239470); f. Innova-EU 6 x 180 x 130 (Batch No. 17339472 17360205 17393388 17507373 17563587 17567306 17621181 17643722 17692709 17751231 17775135 17837622 17893341 17918022 17951215 17977931 18006854 18028547 18065191 18242554 18305612 18412278 18488248 18523620 18688894 18708475 18751464 18802815 18838475 18920656 18999958 19105369 19129190 19178742 19222890 19317120 19367656 19406219 19491632 19597808 19644663 19654080 19664965 19780796 19786768 19815613 19851783 19946633 19984995 20042120 20100778 20127896 20186867 20193387 20260077 20297197 20316561 20378797 20427172 20466862 20478643 20646353 20754062 20797639 20862259 20913445 20980791 21004779 21032769 21178771 21216860 21239475 21276391); g. Innova-EU 7 x 180 x 130 (Batch No. 17351561 17422684 17524012 17662465 17832627 17860677 17916569 17959306 18010628 18028548 18242534 18242556 18320373 18412269 18530138 18592948 18682281 18708601 18785731 18838474 18923775 19021789 19079547 19129191 19178744 19212926 19238403 19317121 19394343 19465187 19693682 19750818 19844551 19907848 20013943 20089474 20199942 20303720 20316576 20413225 20597205 20616293 20685727 20793173 20913448 21096958 21135270 21216475 21250891); h. Innova-EU 8 x 180 x 130 (Batch No. 17349971 17360218 17672512 17951214 18065192 18074216 18320379 19129192 19299435 19635495 19728402 19775531 19946636 20109698 20171185 20495967 20646355 20793176 20818437 21075729 21163790 21240950); i. Innova-China 5 x 180 x 130 (Batch No. 17456003 17456004 17629285 17851466 18077817 18899799 19048094 19474494 19511479 20455112 20539787 20562445 20754066 21045500 21121559 21271047); j. Innova-China 6 x 180 x 130 (Batch No. 17454410 17454411 17454412 17456007 17542769 17629280 17727197 17851471 17988287 19169697 19291890 19327248 20936472 21020803); k. Innova-China 7 x 180 x 130 (Batch No. 17456009 17456010 17463352 17727483 19354376); l. Innova-China 8 x 180 x 130 (Batch No. 17456013 17823505 21130830); m. Innova-China 8 x 180 x 75 (Batch No. 19491836); n. Innova 5 x 180 x 130 (Batch No. 18558414); o. Innova 5 x 180 x 75 (Batch No. 18583366 18611575 18754514); p. Innova 6 x 180 x 130 (Batch No. 18565240 18583363 18644031 18733070 18741089 18744848 18754518 18771910 18780329 18797248 18813744 18823218 18850635 18872987 18886683 18892198 18900363 18913810 18977667 18988346 19013254 19039706 19116474 19129194 19141572 19151411 19164783 19185695 19185696 19188063 19188064 19199363 19212932 19212933 19222885 19240144 19240152 19252774 19267183 19267184 19288822 19288823 19288824 19399366 19464898 19475060 19501338 19511461 19527257 19540740 19545787 19560851 19589364 19609498 19664968 19752067 20109864 20112178 20159642 20186873 20216044 20233666 20247011 20279930 20370769 20394773 20529709 20594722 20602686 20611981 20627806 20628410 20642280 20800467 21098041 21122201 21239472 21239478); q. Innova 6 x 180 x 75 (Batch No. 18563662 18611780 18632059 18733071 18741090 18744849 18751309 18759188 18832543 18839009 18844736 18860228 18866635 18872988 18900364 18913805 18913815 18977668 18988347 19013255 19039707 19048089 19141573 19151412 19173253 19199364 19240153 19262043 19288825 19294325 19309204 19338270 19372772 19399367 19426947 19438864 19500739 19511465 19540552 20159643 20233667 20394774 20430591 20485381 20594723 20611982 20754075 20800468 21244560); r. Innova 7 x 180 x 130 (Batch No. 18558405 18583034 18587957 18620266 18670462 18696465 18713419 18733074 18754519 18785736 18791864 18823243 18886686 18888437 18913807 18920778 18935052 18977677 19006945 19013288 19129197 19139329 19149499 19164785 19173248 19185690 19206077 19228860 19272466 19288833 19309209 19382430 19408968 19408969 19426954 19426955 19464890 19500738 19527254 19597803 19644373 20109866 20138146 20186874 20216046 20244727 20267929 20292468 20611983 20611984 21098798 21135264 21240956); s. Innova 7 x 180 x 75 (Batch No. 18550162 18563667 18604196 18632052 18661523 18670463 18696466 18713940 18741084 18757005 18832542 18839012 18860238 18872997 18900376 18913804 18920779 18935053 18988353 19006946 19013289 19039711 19200146 19205687 19228861 19272467 19288834 19309210 19372774 19394359 19469655 19475063 19501422 19624792 20381125 20547299 21098799 21138681); t. Innova 8 x 180 x 130 (Batch No. 18558400 18623253 18994828 19013299 19027631 19105360 19134319 19291897 19342051 20386606); u. Innova 8 x 180 x 75 (Batch No. 18558401 18623254 19006856 19039535 19089523 19093146 19116680 20386607);" } ] }