Ev3 Pipeline Flex Embolization Device Recalled for Delivery System Fracture Risk
Micro Therapeutics is recalling 762 Ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving parts in the patient.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (foreign object retention) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness or injury.
Plain-English summary
Micro Therapeutics Inc, d/b/a Ev3 Neurovascular, is recalling 762 units of the Ev3 Pipeline Flex Embolization Device with Shield Technology. The device is used for neurological endovascular procedures and was distributed worldwide, including in the United States and numerous international markets.
The recall is due to a potential defect where the delivery system may fracture at the distal section during device implantation. A weakened bond could cause unintended separation, resulting in the distal portion of the delivery system remaining in the patient. The source text notes that if a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
No specific instructions for consumers or healthcare providers are provided in the source text beyond the description of the defect and the risk profile for successfully implanted devices.
The recalled product
- Product
- ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
- Manufacturer
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Affected units
- 762
Distribution
Distributed nationwide across the United States.
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
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