Z-0149-2008

Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile...

Name: Z-0149-2008 Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile...
Creator: Rita Medical Systems, Inc.
Published: 2007-10-03
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-10-03 / Terminated / root cause: manufacturing process

FDA source

Rita Medical Systems, Inc. began a recall of Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816 on 2007-10-03. The reason FDA records is "Incorrect Size Catheter: The product may contain an incorrect size catheter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0149-2008
Status: Terminated
Initiated: 2007-10-03
Posted: 2007-12-28
Terminated: 2008-07-14
Recalling firm: Boston Scientific Corporation
Product: Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: Incorrect Size Catheter: The product may contain an incorrect size catheter.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Notification of the AngioDynamics, Inc. sales force and the domestic and international distributors began on 10/3/2007. Starting on 10/09/2007, Urgent Medical Device Recall letters were sent to all customers requesting that device useage cease and immediate return begin as well as the completion of a fax back form (number of devices used, number to be returned).
Quantity in commerce: 150 kits
Distribution: Worldwide : USA including states of AL, AR, CA, CO, FL, GA, MD, NC, OH, TX, and VT, and countries of Australia, Korea and The Netherlands.
Product codes and lots: Lot #: 30938

Product code LJT

K010189Class IIVortex Access SystemHorizon Medical Products, Inc. / cleared 2001-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)