FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon Catalog # 4545
- Recall number
- Z-0552-03
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon Catalog # 4545
- Status
- Terminated
- Initiated
- 2003-01-29
- Posted
- 2003-02-08
- Terminated
- 2004-03-10
- Reason
- Breach in sterile barrrier may compromise sterility
- 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
- 255 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 5175575 5185073 5185074 5185075 5193211 5193212 5193213 5193920 5196902
- 510(k) numbers
- K970052
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3001451463
- Firm city
- Natick
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28