MISAGO RX Self Expanding Peripheral Stem — Class II medical device recall Z-0669-2017
Terminated recall by Terumo Medical Corp, reported 2016-12-07, distributed nationwide. During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification r
| Recall number | Z-0669-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Medical Corp, Somerset, NJ, United States |
| Recall initiated | 2016-08-04 |
| Classified | 2016-11-29 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2017-10-19 |
| Distributed | Nationwide (US) |
| Quantity | 7,965 units |
Product
MISAGO RX Self Expanding Peripheral Stem
Reason for recall
During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.
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-0669-2017. 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.