Endologix Shares Fall on Catheter RecallDec 14, 2005 | AP
Endologix Inc. shares fell Wednesday after the medical device maker said it could recall up to 35 catheters used to place a device for treating a weakness in the heart's largest artery.
The company said the limited recall affects Powerlink system catheters marketed in the United States. The devices are used to place a graft to treat abdominal aortic aneurysms, where the heart's largest artery weakens and risks rupturing. The company said it received three reports where the tip of the catheter became detached during surgery. Catheters in development and those marketed in Europe are of a different design and not affected by the recall.
Paul McCormick, an Endologix spokesman, said the company has sold from 350 to 400 of the catheters in the United States since their launch in January. He said about 35 catheters are now out at hospitals and the company is aggressively testing all lots of finished catheters in inventory, to see which ones pass muster in order to keep supplies available.
The Food and Drug Administration classified the action as a Class II recall, meaning the device could cause a temporary or reversible adverse event. The company said it is working with the FDA on the recall.
The company said it expects to take a one-time charge of about $700,000 to $800,000 in the current quarter as a result.
Endologix shares fell 46 cents, or 7.3 percent, to $5.70 after being halted briefly during afternoon trading on the Nasdaq. Shares have traded between $4 and $7.24 over the past 52 weeks.