Z-0404-05

VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN...

Name: Z-0404-05 VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN...
Creator: Boston Scientific Corporation
Published: 2004-11-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-11-22 / Terminated

FDA source

Boston Scientific Corporation began a recall of VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN #M001454510, Firm on label: Boston Scientific, One... on 2004-11-22. The reason FDA records is "Catheter separation immediately distal to the nose of the suture wing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0404-05
Status: Terminated
Initiated: 2004-11-22
Posted: 2005-01-20
Terminated: 2005-12-16
Recalling firm: Boston Scientific Corporation
Product: VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN #M001454510, Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains catheter, cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; StatLock Catheter Securement Device, Instructions for Use; Peelaway Sheath Introducer; 10 mL Syringe; CSR Wrap.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Catheter separation immediately distal to the nose of the suture wing.
FDA root cause: Other
Action: Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
Quantity in commerce: 167 kits
Distribution: 75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
Product codes and lots: 933284

Product code LJS

K021704Class IIVaxcel Picc with Pasv Valve TechnologyCatheter Innovations, Inc. / cleared 2002-06-06

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)