Endologix, Inc. today announced the limited voluntary recall of 30 Visiflex™ bifurcated delivery catheters for its Powerlink® System (models 25-16-155BL and 28-16-155BL) located at seven customer sites. Based on a single field occurrence due to the failure of a catheter component manufactured by a third party, the Company has determined that these catheters should be recalled. No other delivery catheters for the Powerlink® System are affected.
This particular component is used in one specific catheter length (155 mm), which is utilized in approximately 15% of Powerlink procedures. In many instances, other catheter lengths can be used for these cases. Endologix does not expect this action to limit its ability to supply other Visiflex delivery catheters to the market.
Endologix has notified the U.S. Food and Drug Administration (FDA) Los Angeles District Office and intends to initiate and rapidly complete this voluntary recall.
“We initiated this voluntary action based on a single clinical incident involving separation of the front sheath preventing deployment of the stent graft. 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,” said Paul McCormick, chief executive officer of Endologix.
“This action affects a very limited number of devices and because the defect can be identified by non-destructive testing, we anticipate that the financial impact to Endologix will not be material,” Mr. McCormick added. All affected consignees have been contacted and instructed to return the specified product to Endologix.