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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0381-2022
Event ID89034
Event DescriptionBoston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.
Quantity7 devices
Recall ReasonManufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Device Classification20211222
Device Code InfoUS Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076; EU Serial number RP005010, GTIN 08714729975151.
Center Classification Date20211215
Recall Initiation Date20211108
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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