Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port, Implantable Port System, Model # M001452380, Catalog #45-238
FDA Recall Z-0733-04 · Posted 2004-07-20
Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLJT
Date Initiated2004-02-10
Date Terminated2005-10-25
Product Quantity199
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.