Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0381-2022 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeMCX
Date Initiated2021-11-08
Date Terminated2023-05-02
Product Quantity7 devices

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.

Firm Action

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.

Root Cause

Employee error

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑