In April 2014, the company 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.
Covidien has identified the coating issue in its ongoing internal product testing and alerted customers to the recall by letter on 1 April 2014.
The company noted that it has not received reports at this time of any patient incidents related to this issue.
Alligator device’s core wire is also coated with PTFE and the same manufacturing process changes to the application of the PTFE coating, which were incorporated into the Pipeline device apply to the Alligator device.
In addition, the company has submitted to the FDA a Special 510(k) change in the manufacturing process for the Alligator device.
The Pipeline device has been developed for the endovascular treatment of adults, aged 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 indicated for use in the peripheral and neuro-vasculature for foreign body retrieval.
