Z-0553-03

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

Name: Z-0553-03 Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon15.5 mm balloon Catalog # 4546
Creator: Boston Scientific Corporation
Published: 2003-01-29
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-01-29 / Terminated / root cause: sterility

FDA source

Boston Scientific Corporation began a recall of Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon15.5 mm balloon Catalog # 4546 on 2003-01-29. The reason FDA records is "Breach in sterile barrrier may compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0553-03
Status: Terminated
Initiated: 2003-01-29
Posted: 2003-02-08
Terminated: 2004-03-10
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon15.5 mm balloon Catalog # 4546
Reason for recall: Breach in sterile barrrier may compromise sterility
Root cause tag: sterility
FDA root cause: Other
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.
Quantity in commerce: 30
Distribution: Nationwide
Product codes and lots: Lot Number: 5184800

K970052Class IIExtractorrxBoston Scientific Corp / cleared 1997-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)