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Pipeline Embolization Device (PED). Used endovascular… recallZ-1453-2014 · Micro Therapeutics Inc, Dba Ev3 Neurovascular · initiated Apr 1, 2014

Class I Terminated All recalls posted in April 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Micro Therapeutics Inc, Dba Ev3 Neurovascular or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.

FDA root cause category: Process change control

What the company is doing

A customer notification letter was sent on 4/1/14 to all customers who purchased the Pipeline Embolization Device and the Alligator Retrieval Device. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer response form and fax the completed form to Covidien at (763) 591-3519. Customers with questions are instructed to contact Dr. Mark A. Turco at (202) 310-5120. A press release was sent on 4/11/14 to Business Wire Newsroom to inform the public about the recall from Covidien. The recall is regarding certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate adn detach from the devices. Consumers are instructed to report any adverse reactions or quality problems experienced with the use of the product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Consumers with may also contact Covidien Customer Service at (800) 716-6700 between 7am to 7pm (central) or email at [email protected].

Recall details

Recall number
Z-1453-2014
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Apr 1, 2014
Posted by the FDA
Apr 16, 2014
Recalling firm
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Quantity
32 units total (23 units in US)
Product code
DQY
FDA submissions
P100018
Distribution
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.

Product description

Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.

Code information (models, lots, serial numbers)

PED Model/ Lot  FA7735014 / 9879718  FA7742512 / 9864827 FA7150035 / 9855921 FA7735016 / 9856429  FA7742518 / 9856431 FA7730010 / 9869991  FA7737514 / 9855933  FA7742518 / 9860762 FA7732514 / 9873854  FA7737516 / 9858010  FA7745014 / 9874111 FA7735014 / 9855265  FA7740016 / 9859214  FA7745016 / 9879736 FA7735014 / 9875267  FA7740016 / 9879180  FA7747514 / 9868888

Other devices under the same FDA submission

292 devices cleared under P100018 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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