Recall Class: Class I
Date Recall Initiated: April 1, 2014
Products: Pipeline Embolization Device and Alligator Retrieval Device
Affected products were manufactured and distributed from May 2013 to March 2014.
Use: The Pipeline Embolization Device is used 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 Retrieval Device is used to remove foreign bodies in the peripheral and neurovasculature.
These devices are coated with polytetrafluoroethylene (PTFE) to reduce friction and ease movement of the device through the blood vessels.
Covidien (ev3 Neurovascular)
9775 Toledo Way
Irvine, CA 92618
Reason for Recall:
The devices have the potential for the PTFE coating to delaminate and detach from the delivery wire. PTFE particulate resulting from the delaminated coating can cause a blockage (embolism) in blood vessels in the brain with the risk of stroke and/or death. The firm received one report of an incident in which the delamination occurred, with zero injuries and zero deaths.
For more information or to report a problem, please contact Covidien Customer Service at 1-800-716-6700, Monday – Friday, 7 a.m. - 7 p.m., Central Time or by email at CustomerServiceUS@Covidien.com.
FDA District: Los Angeles District Office
More Information about this Recall:
On April, 1, 2014, Covidien sent Urgent Product Recall letter to all affected customers. The letter identified the product, problem and the actions to be taken.
For affected products that have been used, no action is necessary and patients should continue to be managed according to standard care.
Covidien is requesting that unused devices be returned to Covidien for replacement with products that are not impacted by this issue.
Covidien instructed their customers to:
- Stop using the affected product immediately.
- Separate the affected product from the other inventory.
- Fill out the reply form at the end of the letter.
- If you do not have any product identified in the letter, please fax the completed form to Covidien at (763) 591-3519.
- If you do have the product, please contact Customer Service at (800) 716-6700 to request an RGA number for the return of the affected product back to Covidien.
- Please fax the completed form with RGA number to Covidien Neurovascular at (763) 591-3519
- Please write the RGA number on the FEDEX slip and send the product back to Covidien.
- Ship product to:
Attention: Product Recall
14005 13th Ave
Plymouth, MN 55441
- Prepaid and pre-addressed FEDEX slips are enclosed for your convenience.
- Ship product to:
- Covidien will ship replacement units directly to you.
About Class I Recalls:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.