“After an internal investigation, VSI has concluded there is a potential for excess material used to manufacture the catheter 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 a procedure, posing a potential risk of an embolism to the patient,” the company wrote in an April 25 letter to customers.
Vascular solutions said there have been no reports of adverse events due to the issue. The affected devices are the Venture RX, Venture OTW and Venture CS catheters. Affected devices (lot numbers can be found here) should be quarantined ahead of being returned to the company for credit.
The $1 billion merger with Teleflex closed in February, bringing a portfolio of more than 90 coronary and peripheral vascular devices under the Teleflex umbrella. When the deal was announced last December, Teleflex CEO Benson Smith said that part of the acquisition’s appeal was that the portfolio creates synergies because it “fits into our existing strategic business unit franchises and call points.”