Boston Scientific — Class II medical device recall Z-0971-2014
Terminated recall by Boston Scientific Corporation, reported 2014-02-19, distributed in AL, CA, FL, IL, IN, MI, MO, NY…. Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilata
| Recall number | Z-0971-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2014-02-04 |
| Classified | 2014-02-11 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2014-08-04 |
| Distributed | AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX |
| Countries outside the US | DE, FR, GB, IN, IT, JP, NL, RU |
| Quantity | 35 for |
| Model numbers | 39185-20151 |
Product
Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
Reason for recall
Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. T
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-0971-2014. 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.