Covidien Recalls More Than 650 Endovascular Treatment Devices

(RTTNews) - Healthcare products company Covidien plc (COV) said Friday that it has issued a voluntary recall of more than 650 endovascular treatment devices, saying that the polytetrafluoroethylene or PTFE coating applied to the delivery wire could delaminate and detach from the devices.

PTFE coating is used to reduce friction between devices and ease navigation through the vasculature. Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature with the risk of stroke or death.

According to Covidien, the recall includes certain lots of its Pipeline Embolization Device and Alligator Retrieval Device. The company has alerted customers of the recall by letter on April 1, 2014 and is arranging for replacement of the recalled products. It has also notified the U.S. Food and Drug Administration or FDA and other regulatory bodies about the recall.

The Pipeline Embolization Device is indicated for the endovascular treatment of adults, aged 22 years and above, with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. The Alligator Retrieval Device is intended for use in the peripheral and neuro-vasculature for retrieval of foreign body.

Covidien said it learned of this issue through internal product testing and has not received any reports of patient injuries to date related to this issue.

Covidien is recalling a total of 32 Pipeline Embolization Devices and 621 Alligator Retrieval Devices. The products were manufactured and distributed from May 2013 to March 2014. This issue involves both the Pipeline Embolization Device sold in the U.S., Australia, France, Germany and UK, and the Alligator Retrieval Device sold in the U.S., Australia, Canada, Europe and Latin America.

Covidien expects the recall to have a slight negative effect on its sales and earnings in the second half of fiscal 2014. However, the company noted that the total impact may increase depending on the timing of replacing the recalled products.

In Friday's regular session, COV is trading at $69.32, down $0.87 or 1.24 percent on a volume of 370,353 shares.