Teleflex Inc. has issued a worldwide recall of more than 4,000 surgical catheters made by its Maple Grove subsidiary Vascular Solutions in an action that has been classified by regulators as a Class 1 recall, the most serious category.
Catheters are thin medical devices used during minimally invasive surgeries. They’re made to fit inside a blood vessel to avoid the need for an “open” surgical procedure. The catheters affected by the recall are used to deliver tiny surgical devices to the blood vessels in the heart and legs, and to manually deliver saline or diagnostic contrast liquid to the body during medical procedures.
Vascular Solutions announced in April that it was voluntarily recalling 4,679 units of Venture catheters because of a risk that “excess material” inside the device may break free during a medical procedure and enter the body, creating a risk of embolism.
Although there have been no reports of harm to patients, the company advised hospitals not to use the affected devices, which should instead be set aside to be returned to the company.
The corrective action applied to unexpired lots of Venture RX Model 5820, Venture OTW Model 5821 and Venture CS Model 5822 catheters that carry one of 73 lot numbers listed in the safety letter.
After the close of business Thursday, Teleflex announced that the Food and Drug Administration has classified the recall as a Class 1 action, which means there is a reasonable probability that the use of the device may cause serious adverse health consequences or death.
On Feb. 17, Wayne, Pa.-based Teleflex Inc. acquired longtime Minnesota device firm Vascular Solutions in a $56-per-share deal valued at more than $1 billion.