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Recall Observatory FDA recall evidence

Device product

Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).

Z-0381-2022

November 08, 2021

Class II

Product summary

Firm
Boston Scientific Corporation
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

    reason.no_named_rule · v1.0.0

    Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.