On April 27th, 2017, the Food and Drug Administration (FDA) has announced a recall of Venture catheters due to the risk of the devices splitting or separating during use. This is considered a Class I recall, which is the most serious type of recall since these devices may result in serious injuries or death.
Excess material, located at the tip of the catheter, may separate and could enter the patient’s bloodstream. This can cause a serious adverse health effect such as the development of blood clots, embolism of the excess material to vital organs, and death.
The recalled products include:
- Venture RX Catheter (Model 5820)
- Venture OTW (Model 5821)
- Venture CS Catheter (Model 5822)
Distribution dates are May 7, 2015 to April 19, 2017. Manufacturing Dates are May 7, 2015 to March 31, 2017. So far, 7054 devices have been recalled throughout the United States. Check out the full list of affect numbers on the FDA site.
Distributors and customers should identify and remove any affected Venture catheters from inventory and quarantine. Distributors should make sure all customers who received any affected devices receive the Field Safety Notice and fill out a Customer Injury Form.
Once all affected catheters are sent back, complete the Vascular Solutions Inc. Distributor Inventory Form, and return it via email to email@example.com. Vascular Solutions' Customer Service Department will provide a Return Authorization number and arrange for return of affected Venture catheters once the Distributor Inventory form has been received. A credit will be offered after affected devices have been returned.