FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990
- Recall number
- Z-0122-2007
- Recalling firm
- Boston Scientific Corporation
- Product
- Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990
- Status
- Terminated
- Initiated
- 2005-08-10
- Posted
- 2006-11-01
- Terminated
- 2012-05-16
- Reason
- Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04
- Root cause
- Other
- Action
- Recall notification packages including a Reply Verification Tracking Form were sent to Boston Scientific representatives via Fed Ex on 8/10/2005. Boston Scientific representatives delivered the packages to the consignees. The Consignees were instructed to return affected product to Boston Scientific to be relabeled.
- Quantity
- 5 units
- Distribution
- TX, KY
- Lot, serial or model codes
- Lot Number: 7552069
- 510(k) numbers
- ["K000177"]
- PMA numbers
- not on file
- Product code
- KRA
- 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