Recalls / —

—#25919

Product

Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon15.5 mm balloon Catalog # 4546

510(k) numbers

K970052

Affected lot / code info

Lot Number: 5184800

Why it was recalled

Breach in sterile barrrier may compromise sterility

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Boston Scientific Place, Natick, Massachusetts 01760

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2003-01-29

Posted by FDA

2003-02-08

Terminated

2004-03-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #25919. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.