FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338, Material #M001453380. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
- Recall number
- Z-0946-05
- Recalling firm
- Boston Scientific Corporation
- Product
- Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338, Material #M001453380. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
- Status
- Terminated
- Initiated
- 2005-06-08
- Posted
- 2005-06-30
- Terminated
- 2007-02-15
- Reason
- Potential for port housing separation after implantation.
- Root cause
- Other
- Action
- A recall package issued to direct accounts on 6/8/05. Hospitals are instructed to return product in inventory, notify physicians, evaluate patients and explant devices whenever possible.
- Quantity
- not on file
- Distribution
- Product shipped to 56 medical facilities throughout the U.S.
- Lot, serial or model codes
- 791549, 915868, 919482, 922594, 923705, 1000906, 1001279, 1003265, 1022911, 1034615, 922594D, 923705D
- 510(k) numbers
- ["K032375","K032600"]
- PMA numbers
- not on file
- Product code
- LLD
- 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