Ev3 Neurovascular Recalls Pipeline Embolization Devices Due to Coating Defect
Ev3 Neurovascular is recalling 32 Pipeline Embolization Devices because the PTFE coating may delaminate and detach from the delivery wire.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device used for intracranial aneurysms, which fits the rubric criterion for 'structural vehicle defect' (analogous structural defect in a medical device) or 'significant injury/property-damage reports' (implied high risk of harm from device failure in a critical area).
Plain-English summary
Micro Therapeutics Inc, dba Ev3 Neurovascular, is recalling 32 units of the Pipeline Embolization Device (PED). These devices are used for the endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
The recall is being conducted because of a potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire. The affected units were distributed worldwide, including in the United States (nationwide, including Puerto Rico) and in Australia, Germany, France, the UK, Turkey, Argentina, Canada, Colombia, Mexico, Austria, Belgium, Denmark, Hungary, Italy, the Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and the UAE.
Healthcare providers and patients should contact Ev3 Neurovascular for instructions on how to proceed with the recall. The source text does not specify specific actions for consumers beyond the recall notification.
The recalled product
- Product
- Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Category
- Medical Device — Neurovascular
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same manufacturer · Micro Therapeutics Inc, Dba Ev3 Neurovascular
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Similar recalls
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FDA (Devices) · 2016-11-16
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