Z-0731-04

Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port, Implantable Port System, Model #...

Name: Z-0731-04 Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port, Implantable Port System, Model #...
Creator: Boston Scientific Corporation
Published: 2004-02-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-02-10 / Terminated

FDA source

Boston Scientific Corporation began a recall of Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port, Implantable Port System, Model # M001452150, Catalog #45-215 on 2004-02-10. The reason FDA records is "Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0731-04
Status: Terminated
Initiated: 2004-02-10
Posted: 2004-07-20
Terminated: 2005-10-25
Recalling firm: Boston Scientific Corporation
Product: Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port, Implantable Port System, Model # M001452150, Catalog #45-215
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.
FDA root cause: Other
Action: Letters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports.
Quantity in commerce: 786 units
Distribution: Shipments were nationwide to 158 medical facilities nationwide.
Product codes and lots: 866561, 876068, 885270, 885444, 886041, 886398, 887738, 888993, 889702, 890163, 903721

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)