Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K… recallZ-0149-2008 · Rita Medical Systems, Inc. · initiated Oct 3, 2007
Terminated All recalls posted in December 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Rita Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect Size Catheter: The product may contain an incorrect size catheter.
FDA root cause category: Employee error
What the company is doing
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).
Recall details
- Recall number
- Z-0149-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 3, 2007
- Posted by the FDA
- Dec 28, 2007
- Recalling firm
- Rita Medical Systems, Inc.
- Quantity
- 150 kits
- Product code
- LJT
- FDA submissions
- K010189
- 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 description
Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816
Code information (models, lots, serial numbers)
Lot #: 30938
Other devices under the same FDA submission
6 devices cleared under K010189 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vortex P5405KNavilyst Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR4 reports
- Vortex P5305KNavilyst Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- Vortex P5455KNavilyst Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR3 reports
- Vortex P12155KAngiodynamics, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- Vortex P5355KNavilyst Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR2 reports
- Vortex P12105KAngiodynamics, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page