Recalls / —

—#25918

Product

Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon Catalog # 4545

510(k) numbers

K970052

Affected lot / code info

Lot Numbers:  5175575 5185073 5185074 5185075 5193211 5193212 5193213 5193920 5196902

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 #25918. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.