FDA Recalls Pipeline Embolization Devices Due to Coating Delamination
Micro Therapeutics Inc is recalling Pipeline Embolization Devices because PTFE coating may delaminate and enter the bloodstream.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Micro Therapeutics Inc, doing business as Ev3 Neurovascular, is recalling the Pipeline Embolization Device (Pipeline Classic). The recall involves 11,860 units distributed worldwide, including nationwide in the United States and internationally to numerous countries.
The recall was initiated because delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating entering the bloodstream. The device is indicated for the endovascular treatment of adults with large or giant widenecked intracranial aneurysms in the internal carotid artery.
The FDA has classified this recall as Class I, which is the most serious type of recall. Patients who have had this device implanted should contact their healthcare provider for guidance on monitoring and potential follow-up care.
The recalled product
- Product
- Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal sege
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Category
- Medical Device — Neurovascular
- Affected units
- 11,860
Distribution
Part of a larger recall action
This product is one of 4 recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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- SevereEv3 Neurovascular Recalls Pipeline Embolization Devices Due to Coating Defect
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