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/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon Catalog # 4544

FDA Recall Z-0551-03 · Posted 2003-02-08

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Date Initiated2003-01-29
Date Terminated2004-03-10
Product Quantity22 units

Reason for Recall

Breach in sterile barrrier may compromise sterility

Firm Action

Boston Scientific/Microvasive, Natick, MA initiated a voluntary recall by letter dated 1/27/03, and mailed 1/29/03. Accounts were requested to remove affected lots and return product to Boston Scientific. A verification form was provided to monitor effectiveness of the recall notification. Non-reponders will be recontacted.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970052EXTRACTORRXBoston Scientific Corp · 1997-03-25

Official Source

View FDA Recall →

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

↑