Z-0946-05

Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338...

Name: Z-0946-05 Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338...
Creator: Boston Scientific Corporation
Published: 2005-06-08
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-06-08 / Terminated

FDA source

Boston Scientific Corporation began a recall of Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338, Material #M001453380. Firm on label: Boston Scientific... on 2005-06-08. The reason FDA records is "Potential for port housing separation after implantation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0946-05
Status: Terminated
Initiated: 2005-06-08
Posted: 2005-06-30
Terminated: 2007-02-15
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.
Product code: LLD Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Reason for recall: Potential for port housing separation after implantation.
FDA 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.
Distribution: Product shipped to 56 medical facilities throughout the U.S.
Product codes and lots: 791549, 915868, 919482, 922594, 923705, 1000906, 1001279, 1003265, 1022911, 1034615, 922594D, 923705D

Product code LLD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)