Z-0630-2007

Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter...

Name: Z-0630-2007 Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter...
Creator: Boston Scientific Corp
Published: 2006-09-27
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-09-27 / Terminated / root cause: packaging

FDA source

Boston Scientific Corp began a recall of Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150 on 2006-09-27. The reason FDA records is "Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0630-2007
Status: Terminated
Initiated: 2006-09-27
Posted: 2007-03-15
Terminated: 2007-11-26
Recalling firm: Boston Scientific Corporation
Product: Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150,
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised.
Root cause tag: packaging
FDA root cause: Other
Action: On 9/27/06, Boston Scientific Corp. sent Urgent Medical Device Recall - Immediate Action Required letters (dated 9/27/06) via Federal Express to the 84 end users (medical facilities). The letters informed the users of the recall of the products due to a compromised sterile barrier. The letters instructed the users to immediately remove the affected lots from inventory, segregate them, contact Boston Scientific at 1-800-862-1284 to obtain a Return Authorization (RGA) number, return the product in an appropriate shipping carton, place the label on the outside of the shipping box, write the RGA # on the outside of the shipping carton, and return the recalled product to Boston Scientific Corp. Distribution Center, Attn: QA Returns, 500 Commander Shea Blvd., Quincy, MA 02171. Accompanying each letter was a Reply Verification Tracking Form to be completed by the user, and mailed or faxed back to Boston Scientific.
Quantity in commerce: Domestic - 194
Distribution: Nationwide
Product codes and lots: Lots 1137363, 1137364, 1137733, and 1137734

Product code LJT

K030083Class IIVaxcel with Pasv PortBoston Scientific Corp / cleared 2003-01-28

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)