Medical Devices

Covidien, Pipeline Embolization Device and Alligator Retrieval Device - (Certain Catalog / Lot Numbers) - Coating on Delivery Wire Could Delaminate and Detach

Recall Class: Class I

Date Recall Initiated: April 1, 2014

Products: Pipeline Embolization Device and Alligator Retrieval Device

Catalog and Lot Numbers: See below for Pipeline Embolization Device and Alligator Retrieval Device catalog and lot numbers.

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.

Recalling Firm:
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.

Public Contact:
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.

Next Steps:

Covidien instructed their customers to:

  1. Stop using the affected product immediately.
  2. Separate the affected product from the other inventory.
  3. 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
  4. Please write the RGA number on the FEDEX slip and send the product back to Covidien.
    • Ship product to:
      Covidien
      Attention: Product Recall
      14005 13th Ave
      Plymouth, MN 55441
    • Prepaid and pre-addressed FEDEX slips are enclosed for your convenience.
  5. 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.

Additional Resources:

Pipeline Embolization Devices:

PED CatalogLot
FA77350149879718
FA77425129864827
FA71500359855921
FA77350169856429
FA77425189856431
FA77300109869991
FA77375149855933
FA77425189860762
FA77325149873854
FA77375169858010
FA77450149874111
FA77350149855265
FA77400169859214
FA77450169879736
FA77350149875267
FA77400169879180
FA77475149868888

Alligator Retrieval Devices:

CatalogLot
FA88810409769118
FA88810309816048
FA88810409754682
FA88810509772283
FA88810409752800
FA88810309751662
FA88810309773525
FA88810209832735
FA88810409757667
FA88810209774620
FA88810309834039
FA88810409758530
FA88810209774620
FA88810309834039
FA88810309758532
FA88810309783730
FA88810209836553
FA88810509760946
FA88810409786013
FA88810309834039
FA88810309761690
FA88810409787928
FA88810509848544
FA88810209761692
FA88810309791385
FA88810309848543
FA88810309758532
FA88810409793305
FA88810309853152
FA88810409764206
FA88810309798648
FA88810309854769
FA88810409764206
FA88810309798648
FA88810309858153
FA88810409764212
FA88810509801041
FA88810309865759
FA88810309766949
FA88810209811215
FA88810509868025
FA88810309769117
FA88810309813908

Page Last Updated: 06/03/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.