Teleflex Incorporated announced the worldwide recall of Venture Catheters, which was recently initiated by Vascular Solutions Inc., the Teleflex subsidiary that manufactures the catheters. The recall was initiated because 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. To date, there have been no reports of serious injury or deaths associated with this issue.
Affected Rapid Exchange (RX), Over-the-Wire (OTW) and Coronary Sinus (CS) catheters are used in cauterization procedures to direct, steer, control and support a guidewire to access discrete regions or the coronary and peripheral vasculature. Two versions may be used for manual delivery of saline solution or diagnostic contrast agents.
The Food and Drug Administration (FDA) has classified the recall as a Class I, which involves situations in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death.
The worldwide recall affects 4,679 units that were distributed in the U.S. All unexpired lots of the RX, OTW and CS catheters are affected by the recall.
Vascular Solutions has notified medical facilities of the recall through an Urgent Medical Device Recall letter and instructed them to remove their products from their inventory and return them to Vasvular Solutions.
Any adverse events related to these recalled Venture Catheters should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
FDA Recall Notice