Recall Z-0403-05 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
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 lu
| Date | Jan 20, 2005 (initiated Nov 22, 2004) |
| Status | Terminated |
| Reason | Catheter separation immediately distal to the nose of the suture wing. |
| 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 | 1,218 units |
| Distribution | 75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021704 | VAXCEL PICC WITH PASV VALVE TECHNOLOGY Catheter Innovations, Inc., Jun 6, 2002 |