Boston Scientific Corporation 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 cathe Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 cathe
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
913404, 913661, 917962, 924521, 930616, 936038, 943745, 950540, 950969, 3010403046, 3010403102, 3010803014, 3010803015, 3010803016, 3010803178, 3011002259, 3011102034, 3011102035
Products Sold
913404; 913661; 917962; 924521; 930616; 936038; 943745; 950540; 950969; 3010403046; 3010403102; 3010803014; 3010803015; 3010803016; 3010803178; 3011002259; 3011102034; 3011102035;
Boston Scientific Corporation is recalling VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen. Catalog #45-450, UPN #M001454 due to Catheter separation immediately distal to the nose of the suture wing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Catheter separation immediately distal to the nose of the suture wing.
Recommended Action
Per FDA guidance
Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026