Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Teleflex’s (TFX) Vascular Solutions, Inc. Issues Recall of Venture® Catheters

For Immediate Release

June 22, 2017

Contact

Consumers

customerservice@vasc.com
1-888-240-6001
 

Announcement

Vascular Solutions, Inc. voluntarily initiates a worldwide recall of Venture Catheters on April 25, 2017

Teleflex Incorporated (NYSE: TFX), announces a worldwide recall of Venture® Catheters was voluntarily initiated by its Vascular Solutions, Inc. subsidiary on April 25, 2017. Vascular Solutions, Inc. is the manufacturer of Venture Catheters, which are designed for use in catheterization procedures, to direct, steer, control, and support a guidewire to access discrete regions of the coronary and peripheral vasculature. Two versions may also be used for manual delivery of saline solution or diagnostic contrast agents.

The U.S. Food and Drug Administration (FDA) classified this as a Class I recall. The FDA defines Class I recall as, "a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death."

The worldwide recall affects 4,679 units distributed in the United States. All unexpired lots of the Rapid Exchange (RX), Over-the-Wire (OTW), and Coronary Sinus (CS) versions of the product have been recalled due to the potential for excess material to be present within the inner lumen of the distal catheter tip. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury. No serious injuries or death have been reported in association with this issue to date.

Vascular Solutions, Inc. initiated the recall through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. Healthcare facilities with affected Venture Catheters should remove the products from their inventory and return them to Vascular Solutions, Inc. The notification identified the specific unexpired lots subject to the recall and included instructions on how to return the affected products to Vascular Solutions, Inc.

Vascular Solutions, Inc. has notified the FDA of this action.

Vascular Solutions, Inc. Venture Catheters Affected Product Codes and Lots.

Product CodeLot
5820582455
5820582588
5820583022
5820583409
5820584469
5820584470
5820585180
5820585458
5820585787
5820587035
5820587036
5820587775
5820588097
5820588098
5820588794
5820589885
5820589886
5820590172
5820590776
5820591196
5820591198
5820592080
5820592526
5820593080
5820593519
5820593720
5820594204
5820594421
5820595195
5820595418
5820597293
5820597771
5820597967
5820598903
5820599045
5820599466
5820599903
5820601745
5820603987
5820603988
5820603991
5820604500
5821581713
5821583410
5821584471
5821585459
5821586408
5821586972
5821587408
5821588099
5821589268
5821589754
5821590404
5821591197
5821592081
5821592924
5821593520
5821595196
5821595419
5821596020
5821597294
5821599650
5821601196
5821601746
5821602260
5821603990
5821604049
5821605617
5822588100
5822590562
5822597905
5822599777
5822604862

Consumers with questions may contact the company by phone at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at customerservice@vasc.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

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Page Last Updated: 06/23/2017
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