FDA Device recall Z-0686-2018
Innova Self-Expanding Stent System, 180mm
- FDA Device
- Class II
- ongoing
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of Innova Self-Expanding Stent System, 180mm by Boston Scientific, citing stent possibly unable to be fully released from the delivery system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0686-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-11-06 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | US |
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
Stent possibly unable to be fully released from the delivery system.
Identifiers
| code_info | a. Innova-EU 5 x 180 x 75 (Batch No. 17520924 18202150 18759183 19079259 19699151 19699152 19699153 19699154 19…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 202050 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0686-2018%22
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