Recall Z-0781-05 ยท LLD Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Boston Scientific Corporation
Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
| Date | Apr 28, 2005 (initiated Feb 25, 2005) |
| Status | Terminated |
| Reason | Potential separation of the port base from the port cover after implantation. |
| Root cause | Other |
| Action | Letters sent 3/11/2005 via Federal Express to hospitals receiving affected product. Customers instructed to remove/return product, notify physicians, evaluate patients and explant devices whenever possible. |
| Quantity | 214 units |
| Distribution | 1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031844 | VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 Boston Scientific Corp, Jul 15, 2003 |