Boston Scientific Corporation
Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001PRTB10A. Firm on label: Boston Scientific Corp., NAMIC Technology Center, Glens Falls, NY 12801.
| Date | Jul 20, 2004 (initiated Mar 29, 2004) |
| Status | Terminated |
| Reason | Catheters may not have adequate radiopacity for proper visualization under fluoroscopy. |
| Root cause | Other |
| Action | Letters dated 3/29/04 with instruction to remove and return product. |
| Quantity | 72 units |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991897 | CATHETER INNOVATIONS IMPLANTABLE PORT Catheter Innovations, Inc., Oct 21, 1999 |