Boston Scientific ROTAPRO — Class II medical device recall Z-0381-2022
Terminated recall by Boston Scientific Corporation, reported 2021-12-22, distributed nationwide. Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROT
| Recall number | Z-0381-2022 |
|---|---|
| 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 | 2021-11-08 |
| Classified | 2021-12-15 |
| Reported by FDA | 2021-12-22 |
| Terminated | 2023-05-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Quantity | 7 devices |
| UPC / GTIN / UDI-DI | 08714729975076, 08714729975151 |
| Serial numbers | RP005005, RP005010, RP005013, RP005017, RP005036, RP005039, RP005040 |
| Model numbers | H74939309010 |
Product
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Reason for recall
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
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-0381-2022. 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.