Endologix Recalls Visiflex Catheters

Irvine, CA-based Endologix has voluntarily recalled 30 Visiflex bifurcated delivery catheters for its Powerlink System that are located at seven customer sites, according to the Associated Press.

The manufacturer of minimally invasive treatments for vascular diseases decided to recall the catheters after a single occurrence related to the failure of a catheter part made by a third party. No other delivery catheters for the Powerlink System are affected.

Endologix said this particular component is used in one specific catheter length (155 mm), which is used in about 15% of Powerlink procedures. In many instances, other catheter lengths can be used for these cases, the company said.

Endologix does not expect this action to limit its ability to supply other Visiflex delivery catheters to the market. The company notified FDA about the recall.

“We initiated this voluntary action based on a single clinical incident involving separation of the front sheath preventing deployment of the stent graft,” said CEO Paul McCormick. “This required the physician to convert the patient to conventional open repair. We have pro-actively identified corrective actions at Endologix to ensure the quality of purchased catheter components, and we are working with our component vendors to resolve this issue.”

The company said that since the recall is limited and the defect can be identified by non-destructive testing.