Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling ROTAPRO Rotational Atherectomy System Console devices due to a manufacturing instruction deficiency. The manufacturing instructions failed to include directions to prevent retesting of the pneumatic kit component upon failure, which constitutes an internal nonconformity. Seven devices are affected: six units in the United States (distributed in Florida, Nevada, New York, Ohio, Pennsylvania, and Washington) and one unit in Germany, identified by specific serial numbers and GTINs.
The affected devices include US serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, and EU serial number RP005010. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
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: Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany. Quantity: 7 devices Lot/code info: US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076; EU Serial number RP005010, GTIN 08714729975151.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.