News | Cath Lab | June 22, 2017

Vascular Solutions Recalls Venture Catheters That May Split or Separate During Use

FDA identified this as a Class 1 recall due to the possibility of components embolizing

The Vascular Solutions Venture catheters were recalled due to tip separation

June 22, 2017 — The U.S. Food and Drug Administration (FDA) has identified Vascular Solutions’ recent recall of its Venture catheters as a Class I recall, it announced this week. This is the most serious type of recall, because the FDA said use of these devices may cause serious injuries or death.

Vascular Solutions initiated a voluntary recall of the guidewires April 25, 2017. The company said 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 embolize into 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.

Recall is for Venture RX Catheter (Model 5820), Venture OTW (Model 5821) and Venture CS  Catheter (Model 5822). These devices were distribution between May 7, 2015 to April 19, 2017, and manufactured between May 7, 2015 to March 31, 2017. The recall includes 7,054 nationwide in the U.S.

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.

The company 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. This includes completing a field safety notice and a customer inventory form. After all the affected catheters are returned, customers are asked to complete the Vascular Solutions Inc. Distributor Inventory Form, and return it via email to [email protected] Upon receipt of the 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, the company said.

Healthcare professionals and consumers may contact Vascular Solutions at (888) 240-6001 Monday through Friday, between the hours of 8 a.m. and 5 p.m. Central Time, or by e-mail at [email protected] with any questions related to this recall.

For a complete list of recalled product codes and lot numbers go to www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm564092.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Related Content:

VIDEO: Basics of Interventional Guidewire Design and Function

Understanding the Design and Function of Guidewire Technology

The Basics of Guide Wire Technology

 

Related Content

Complete Revascularization Superior to Culprit Lesion-only Intervention
News | Cath Lab | September 10, 2019
An international randomized trial has shown that complete revascularization reduces major cardiovascular events...
The cath lab staff UH Portage Medical Center.

The cath lab staff UH Portage Medical Center.

Feature | Cath Lab | September 09, 2019 | Anjan Gupta, M.D., FACC, FSCAI
Primary percutaneous coronary intervention (PCI) is the preferred treatment for acute...
FDA Grants Shockwave Medical Breakthrough Status for Coronary Intravascular Lithotripsy
News | Cath Lab | September 03, 2019
Shockwave Medical Inc. has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA)...
Compound Could Help Improve Heart Attack Recovery
News | Cath Lab | August 27, 2019
Imagine there were a drug that you could take soon after a heart attack that could reduce damage by protecting healthy...
New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Overlay Init