Vortex MP Port Single Titanium Port with Attached (5Fr)… recallZ-3071-2011 · Angiodynamics, INC · initiated Aug 30, 2010
Terminated All recalls posted in August 2011
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 Angiodynamics, 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
The labeling contains errors which result in the products being misbranded
FDA root cause category: Labeling False and Misleading
What the company is doing
AngioDynamics, Inc. sent out a "Medical Device Recall" letter dated August 30, 2010 to all affected customers. The letter included; products affected, problem and asked them to return the product back to AngioDynamics. Customers were asked to fill out and return the included Recall Reply Form. For question on this recall contact AngioDynamics at (800) 772-6446.
Recall details
- Recall number
- Z-3071-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 30, 2010
- Posted by the FDA
- Aug 24, 2011
- Recalling firm
- Angiodynamics, INC
- Quantity
- 69 units
- Product code
- LJT
- FDA submissions
- K033473
- Distribution
- Worldwide Distribution: (USA) Nationwide distribution and the countries of Austria, China, Denmark, Egypt, France Germany, India, Italy, Latvia, Netherlands, Poland, Russian Federation, South Africa, Switzerland and the United Kingdom
Product description
Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter, AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816 Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
Code information (models, lots, serial numbers)
Catalog number: MP-P5SAT, Batch numbers: 513795 and 514961.
Other devices under the same FDA submission
3 devices cleared under K033473 — 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 MP-P5SATNavilyst Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR1 recall7 reports
- Vortex MP-P5SDTNavilyst Medical, Inc. · PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR4 reports
- Vortex MP-P5PTNavilyst Medical, 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