Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter… — Class II medical device recall Z-2674-2017
Terminated recall by Boston Scientific Corporation, reported 2017-07-12, distributed in MI, MO. Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it sho
| Recall number | Z-2674-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2017-06-01 |
| Classified | 2017-07-03 |
| Reported by FDA | 2017-07-12 |
| Terminated | 2018-06-26 |
| Distributed | MI, MO |
| Countries outside the US | AT, ES, FR, GB, IT, SE |
| Quantity | 32 units |
| Reason classes | labeling |
| Lot numbers | 0/2018, 19343209, 6/3 |
Product
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Reason for recall
Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon
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-2674-2017. 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.