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COMPANY ANNOUNCEMENT

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

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.

Read Announcement

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

Summary

Company Announcement Date:
June 22, 2017
FDA Publish Date:
February 09, 2018
Product Type:
Medical Devices
Reason for Announcement:
Recall Reason Description
Due to the potential for excess material to be present within the inner lumen of the distal catheter tip
Company Name:
Teleflex Vascular Solutions, Inc.
Brand Name:
Brand Name(s)
Venture
Product Description:
Product Description
Catheters

Company 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 Code Lot
5820 582455
5820 582588
5820 583022
5820 583409
5820 584469
5820 584470
5820 585180
5820 585458
5820 585787
5820 587035
5820 587036
5820 587775
5820 588097
5820 588098
5820 588794
5820 589885
5820 589886
5820 590172
5820 590776
5820 591196
5820 591198
5820 592080
5820 592526
5820 593080
5820 593519
5820 593720
5820 594204
5820 594421
5820 595195
5820 595418
5820 597293
5820 597771
5820 597967
5820 598903
5820 599045
5820 599466
5820 599903
5820 601745
5820 603987
5820 603988
5820 603991
5820 604500
5821 581713
5821 583410
5821 584471
5821 585459
5821 586408
5821 586972
5821 587408
5821 588099
5821 589268
5821 589754
5821 590404
5821 591197
5821 592081
5821 592924
5821 593520
5821 595196
5821 595419
5821 596020
5821 597294
5821 599650
5821 601196
5821 601746
5821 602260
5821 603990
5821 604049
5821 605617
5822 588100
5822 590562
5822 597905
5822 599777
5822 604862

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.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 
 

Company Contact Information

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