Z-0781-05

Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM...

Name: Z-0781-05 Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM...
Creator: Boston Scientific Corporation
Published: 2005-02-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-02-25 / Terminated

FDA source

Boston Scientific Corporation began a recall of Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM ON LABEL: Boston Scientific MEDI-TECH... on 2005-02-25. The reason FDA records is "Potential separation of the port base from the port cover after implantation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0781-05
Status: Terminated
Initiated: 2005-02-25
Posted: 2005-04-28
Terminated: 2006-08-09
Recalling firm: Boston Scientific Corporation
Product: Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
Product code: LLD Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Reason for recall: Potential separation of the port base from the port cover after implantation.
FDA root cause: Other
Action: Letters sent 3/11/2005 via Federal Express to hospitals receiving affected product. Customers instructed to remove/return product, notify physicians, evaluate patients and explant devices whenever possible.
Quantity in commerce: 214 units
Distribution: 1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control
Product codes and lots: Cat. No. 45-236, including all lots as follows: 791486, 906776, 916194, 917025

Product code LLD

K031844Class IIVaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238Boston Scientific Corp / cleared 2003-07-15

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)