Boston Scientific Corporation Recall 89034
Description: Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Boston Scientific Corporation Recall 89034 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0381-2022 |
| Event ID | 89034 |
| Event Description | Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU). |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany. |
| Quantity | 7 devices |
| Recall Reason | Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity. |
| Device Classification | 20211222 |
| Device Code Info | US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076; EU Serial number RP005010, GTIN 08714729975151. |
| Center Classification Date | 20211215 |
| Recall Initiation Date | 20211108 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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