Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular Due to Embolization device delivery system may fracture at the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Micro Therapeutics Inc, Dba Ev3 Neurovascular directly.
Affected Products
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
Quantity: 762
Why Was This Recalled?
Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Micro Therapeutics Inc, Dba Ev3 Neurovascular
Micro Therapeutics Inc, Dba Ev3 Neurovascular has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report