FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303
- Recall number
- Z-0109-2008
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303
- Status
- Terminated
- Initiated
- 2007-09-10
- Posted
- 2007-10-31
- Terminated
- 2007-12-20
- Reason
- Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.
- Root cause
- Packaging process control
- Action
- Boston Scientific issued a Urgent Medical Device Recall Letter dated September 10, 2007 to Domestic accounts via Federal Express. The notification instructed the account to immediately discontinue the use of the product under this recall, check their inventory, remove any affected product , and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form
- Quantity
- 153
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 9218692; 9218628; 9218451
- 510(k) numbers
- ["K000177"]
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- 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