FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD Titanium Port, Implantable Port System, Model # M001453620, Catalog #45-362
- Recall number
- Z-0732-04
- Recalling firm
- Boston Scientific Corporation
- Product
- Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD Titanium Port, Implantable Port System, Model # M001453620, Catalog #45-362
- Status
- Terminated
- Initiated
- 2004-02-10
- Posted
- 2004-07-20
- Terminated
- 2005-10-25
- Reason
- Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.
- Root cause
- Other
- Action
- Letters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports.
- Quantity
- 364 units
- Distribution
- Shipments were nationwide to 158 medical facilities nationwide.
- Lot, serial or model codes
- 866762, 885272, 887739, 889302, 889704, 892898, 896675, 903724, 904485
- 510(k) numbers
- ["K030083"]
- PMA numbers
- not on file
- Product code
- LJT
- 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