Z-0381-2022 Class II Terminated
FDA device recall Z-0381-2022 was initiated by Boston Scientific Corporation on November 8, 2021 and is designated Class II. 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. The recall status is terminated (terminated May 2, 2023). Affected quantity: 7 devices.
Recall Details
- Product Type
- Devices
- Report Date
- December 22, 2021
- Initiation Date
- November 8, 2021
- Termination Date
- May 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 devices
Product Description
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.
Code Information
US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076; EU Serial number RP005010, GTIN 08714729975151.