Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD Titanium Port, Implantable Port System, Model # M001453620,
FDA device recall Z-0732-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.
- Action taken
- Letters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 364 units
- Distribution
- Shipments were nationwide to 158 medical facilities nationwide.
- Date initiated
- 2004-02-10
- Date posted
- 2004-07-20
- Date terminated
- 2005-10-25
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VAXCEL WITH PASV PORT (K030083) | Boston Scientific Corp | 2003-01-28 |