FDA Medical Device Recalls (openFDA)
Boston Scientific Target: Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570
- Recall number
- Z-0177-2007
- Recalling firm
- Boston Scientific Target
- Product
- Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570
- Status
- Terminated
- Initiated
- 2006-10-13
- Posted
- 2006-11-14
- Terminated
- 2007-12-04
- Reason
- Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct)
- Root cause
- Other
- Action
- On 10/6/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. Product will be destroyed upon return.
- Quantity
- 54 units
- Distribution
- Class III Recall-Worldwide-USA and Australia
- Lot, serial or model codes
- Lot #: 7513978
- 510(k) numbers
- ["K973645"]
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 2939204
- Firm city
- Fremont
- Firm state
- CA
- 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