Boston Scientific Corporation: Medical Device Recall in 2021 - (Recall #: Z-0381-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 8, 2021

Date Posted: December 22, 2021

Recall Number: Z-0381-2022

Event ID: 89034

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.

Status: Terminated

Product Quantity: 7 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated