The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • Venture RX Catheter (Model 5820), Venture OTW (Model 5821), and Venture CS ¬†Catheter (Model 5822)
  • Lot Numbers: See Full List Below
  • Distribution Dates: May 7, 2015 to April 19, 2017
  • Manufacturing Dates: May 7, 2015 to March 31, 2017
  • Devices Recalled in the U.S.: 7054 nationwide

Device Use

The Venture catheter is intended for directing, steering, controlling, and supporting a guidewire to access veins and arteries in the arms, legs, hands, feet, and heart muscle (myocardium). Certain models may also administer saline fluids or drugs into blood vessels.

Image of the device.

Reason for Recall

Vascular Solutions Inc. is recalling the Venture catheter because there is a risk of the catheter tip splitting or separating during use. Excess material at the tip of the catheter may separate and could enter the patient’s bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.

Who May be Affected

  • Health care providers using this device during vascular procedures
  • All patient groups undergoing procedures involving Venture catheters

What to Do

On April 25, 2017, Vascular Solutions Inc. sent an Urgent Medical Device Recall letter to all affected customers. The letter asked distributors and customers to:

  • Identify and remove any affected Venture catheters from inventory and quarantine.
  • Ensure all customers who received any affected Venture catheters receive the Field Safety Notice and complete the Customer Inventory Form.
  • After all the affected catheters are returned, complete the Vascular Solutions Inc. Distributor Inventory Form, and return it via email to regops@vasc.com.
  • Upon receipt of the Vascular Solutions Inc. Distributor Inventory Form, Vascular Solutions’ Customer Service Department will provide a Return Authorization number and arrange for return of affected Venture catheters. A credit will be offered after affected devices have been returned.

Contact Information

Health care professionals and consumers may contact Vascular Solutions 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 with any questions related to this recall.

Date Recall Initiated

April 25, 2017

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

Full list of Product Codes and Lot Numbers

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

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