|Covidien's Pipeline Embolization Device--Courtesy of Covidien|
The FDA approved Covidien's ($COV) fixes to the manufacturing process of its recalled Pipeline Embolization Device and Alligator Retrieval Device for treating brain aneurysms.
In April Covidien recalled more than 650 units of the devices due to concerns over the coating on their delivery wires, which could delaminate and detach from the instruments, saying "delamination of the [Teflon] coating could potentially lead to embolic occlusion in the cerebral vasculature with the risk of stroke and/or death."
Now manufacturing of the devices can begin again. In today's statement, Covidien said that it worked with its suppliers to develop changes to the coating process. Due to the go-ahead from the FDA, the recall is expected to have only a slight negative effect on sales and earnings in Covidien's fourth fiscal quarter of 2014, the statement says.
Soon after the recall was initiated, FDA slapped the company with the agency's most severe, Class I designation, meaning "there is a reasonable probability that use of these products will cause serious adverse health consequences or death," in the agency's words. The FDA also said Covidien reported one instance of delamination, but it did not result in death or injury.
Following internal testing, Covidien recalled 621 of the Alligator devices, which were 510(k) cleared for foreign body removal in the peripheral and neurovasculature, including intracranial use, in 2005. The device is sold in the U.S., Australia, Canada, Europe and Latin America.
Thirty-two Pipeline Embolization Devices were also subject to the recall. That device received premarket approval in 2011 for the treatment of adults with intracranial aneurysms in the internal carotid artery, and has received PMA supplement approvals since then. It is sold in the U.S., Australia, France, Germany and United Kingdom.
- read the release