FDA: Class I Recall for Venture Catheters
The FDA warns that affected lots are at risk for splitting or separating during use, posing a potential for embolism.
The FDA has classified a recent safety notice issued by Vascular Solutions and affecting their Venture catheters as a Class I recall, the agency said today. The catheters are used to direct, steer, control, and support a guidewire to access coronary and peripheral vasculature.
The manufacturer had initiated a field safety notice in April voluntarily removing 73 unexpired lots after an internal investigation concluded that there was a risk of the catheter tip splitting or separating during use. The notice states that it “is possible that the excess material may separate from the catheter during a procedure, posing a potential risk of an embolism to the patient.”
There have been no reports of adverse patient events related to this issue.
The recalled models are Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822). Approximately 7,054 devices subject to recall were distributed nationwide. All were manufactured between May 7, 2015 and March 31, 2017.
L.A. McKeown is a Senior Medical Journalist for TCTMD, the Section Editor of CV Team Forum, and Senior Medical…
Read Full BioSources
US Food and Drug Administration. Venture catheters by Vascular Solutions: Recall - excess material may split or separate during use. Published on: June 21, 2017. Accessed on: June 21, 2017.
Comments