Device product
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Z-0381-2022
Product summary
- Event
- Event 89034
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 devices
- Official record key
device-enforcement:Z-0381-2022
Official wording
Reason: Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Code information: US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076; EU Serial number RP005010, GTIN 08714729975151.
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.
Derived failure modes
-
Unknown
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.