Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port, Implantable Port System, Model # M001452150, Catalog #45-215
FDA Recall Z-0731-04 · Posted 2004-07-20
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLJT
Date Initiated2004-02-10
Date Terminated2005-10-25
Product Quantity786 units
Reason for Recall
Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.
Firm Action
Letters dated 2/9/04 with instructions to return current inventory . Also included is information concerning implanted ports.
Root Cause
Other
Distribution Pattern
Shipments were nationwide to 158 medical facilities nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.