Teleflex (NYSE:TFX) subsidiary Vascular Solutions today updated on a voluntary recall of its Venture Catheters over issues with excess material on the devices, saying that the FDA labeled it as a Class I recall, it’s most serious designation for recalls.
Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The Venture caths are designed to direct, steer, control and support a guidewire through the coronary and peripheral vasculature, with 2 versions of the device for manual delivery of saline solution or diagnostic contrast agents, the Wayne, Penn.-based company said.
Vascular Solutions said the devices are being recalled due to the “potential for excess material to be present within the inner lumen of the distal catheter tip,” according to a press release. Such excess material could separate from the catheter and pose a risk of embolism and result in serious injury, though so far the company has not received any reports of serious injuries or death associated with the catheters.
A total of 4,679 units distributed in the US are affected by the recall, which covers all unexpired lots of the Rapid Exchange, Over-the-Wire and Coronary Sinus versions of the product. The recall affects product codes 5820, 5821 and 5822, with an associated 72 different lot numbers, according to a press release.
The company said it has contacted purchasers with affected products, and advised any facilities with the products to remove them from their inventory and return them.
Vascular Solutions initiated the recall earlier this month, saying it had identified the issue after an internal investigation.