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U.S. Department of Health and Human Services

Class 1 Device Recall Pipeline Embolization Device (PED)

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 Class 1 Device Recall Pipeline Embolization Device (PED)see related information
Date Initiated by FirmApril 01, 2014
Date PostedApril 16, 2014
Recall Status1 Terminated 3 on October 31, 2014
Recall NumberZ-1453-2014
Recall Event ID 67893
PMA NumberP100018 
Product Classification Catheter, percutaneous - Product Code DQY
ProductPipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Code Information 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
Recalling Firm/
Manufacturer		 Micro Therapeutics Inc, Dba Ev3 Neurovascular
9775 Toledo Way
Irvine CA 92618-1811
For Additional Information Contact
949-839-3700
Manufacturer Reason
for Recall		Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
FDA Determined
Cause 2		Process change control
ActionA 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 customerserviceus@covidien.com.
Quantity in Commerce32 units total (23 units in US)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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