—#190351

Product

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

FDA product code: MCX — Catheter, Coronary, Atherectomy
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076; EU Serial number RP005010, GTIN 08714729975151.

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

The recalling firm issued letters dated 11/8/2021 on the same date and flagged "Urgent Medical Device Removal - Immediate Action Required." It explains the reason for recall, the risk to health, and provides removal instructions. The instructions say to immediately discontinue use of and segregate the affected product. A Reply Verification Tracking Form is enclosed for immediate completion and return. The customer will be contacted by BSC and provided a Returned Goods Authorization for return of the device.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.

Timeline

Recall initiated: 2021-11-08
Terminated: 2023-05-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190351. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.