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Terminated

Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD Titanium Port, Implantable Port System, Model # M001453620, Catalog #45-362

FDA Recall Z-0732-04 · Posted 2004-07-20

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLJT
Date Initiated2004-02-10
Date Terminated2005-10-25
Product Quantity364 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.

K030083VAXCEL WITH PASV PORTBoston Scientific Corp · 2003-01-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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