Innova Self-Expanding Stent System — Class II medical device recall Z-0686-2018
Ongoing recall by Boston Scientific Corporation, reported 2018-02-28, distributed nationwide. Stent possibly unable to be fully released from the delivery system.
| Recall number | Z-0686-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2017-11-06 |
| Classified | 2018-02-22 |
| Reported by FDA | 2018-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 22,916 units |
| UPC / GTIN / UDI-DI | 74939293061830 |
| Lot numbers | 17339472, 17349971, 17351561, 17360205, 17360218, 17379136, 17393388, 17422684, 17454410, 17454411, 17454412, 17456003, 17456004, 17456007, 17456009, 17456010, 17456013, 17463352, 17507373, 17515253, 17520924, 17520931, 17524012, 17542769, 17563587, 17567306, 17612617, 17620115, 17621181, 17629280, 17629285, 17643398, 17643722, 17662465, 17672512, 17692708, 17692709, 17727197, 17727483, 17751231 and 460 more |
Product
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);
Reason for recall
Stent possibly unable to be fully released from the delivery system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0686-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.