—#36139

Product

VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen. Catalog #45-450, UPN #M001454500; sold as individual catheters. 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.

FDA product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K021704
Affected lot / code info: 913404; 913661; 917962; 924521; 930616; 936038; 943745; 950540; 950969; 3010403046; 3010403102; 3010803014; 3010803015; 3010803016; 3010803178; 3011002259; 3011102034; 3011102035;

Why it was recalled

Catheter separation immediately distal to the nose of the suture wing.

Root cause (FDA determination)

Other

Action the firm took

Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

Distribution pattern: 75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.

Timeline

Recall initiated: 2004-11-22
Posted by FDA: 2005-01-20
Terminated: 2005-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36139. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.