Covidien plc has announced that the U.S. Food and Drug Administration (FDA) has approved changes to the manufacturing process for the polytetrafluoroethylene (PTFE) coating on the delivery wire of the company’s Pipeline embolization device.
On April 1, 2014, Covidien voluntarily recalled certain lots of Pipeline and Alligator retrieval devices on which the PTFE coating applied to the delivery wire could delaminate and detach from the devices. In the months since, Covidien worked with its suppliers to develop and qualify changes to the coating process.
Given the timely resolution, the recall is expected to have only a slight negative effect on sales and earnings in the fourth-quarter of fiscal 2014.
Covidien learned of the PTFE coating issue that led to the recall through its ongoing internal product testing and alerted customers to the recall by letter on April 1, 2014. The company has not received reports at this time of any patient incidents related to this issue.
The core wire of the Alligator device is also coated with PTFE. The same manufacturing process changes to the application of the PTFE coating that were incorporated into the Pipeline device apply to the Alligator device. Covidien also submitted to the FDA a Special 510(k) change in the manufacturing process for the Alligator device.
The Pipeline device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide‐necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. The Alligator device is intended for use in the peripheral and neuro-vasculature for foreign body retrieval.