FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-994. Firm on the label: Boston Scientific.
- Recall number
- Z-0760-04
- Recalling firm
- Boston Scientific Corporation
- Product
- VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-994. Firm on the label: Boston Scientific.
- Status
- Terminated
- Initiated
- 2004-03-05
- Posted
- 2004-07-20
- Terminated
- 2005-10-26
- Reason
- Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.
- Root cause
- Other
- Action
- Letter dated 3/5/04 with instructions to return product.
- Quantity
- 100 units (box/10)
- Distribution
- 42 domestic hospitals nationwide and one distributor in Canada.
- Lot, serial or model codes
- 910482, Exp. 10/31/05
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DRE
- 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