Pipeline Embolization Device recall
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Why was Pipeline Embolization Device recalled?
Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
- Recalling firm
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Quantity
- 32 units total (23 units in US)
- 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.
- Recall date
- April 23, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)