Z-3071-2011

Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter, AngioDynamics, Inc., One Horizon...

Name: Z-3071-2011 Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter, AngioDynamics, Inc., One Horizon...
Creator: Angiodynamics, INC
Published: 2010-08-30
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-08-30 / Terminated / root cause: labeling and UDI

FDA source

Angiodynamics, INC began a recall of Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter, AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816 Indicated for central... on 2010-08-30. The reason FDA records is "The labeling contains errors which result in the products being misbranded". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3071-2011
Status: Terminated
Initiated: 2010-08-30
Posted: 2011-08-24
Terminated: 2012-03-12
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Reason for recall: The labeling contains errors which result in the products being misbranded
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 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.
Quantity in commerce: 69 units
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 codes and lots: Catalog number: MP-P5SAT, Batch numbers: 513795 and 514961.

Product code LJT

K033473Class IIModification to Vortex Mp Vascular Access PortHorizon Medical Products, Inc. / cleared 2003-11-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)