Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular Due to The firm is recalling Pipeline and Pipeline Flex...
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
-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.
Quantity: 23 devices
Why Was This Recalled?
The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.
Where Was This Sold?
This product was distributed to 9 states: IL, KY, MD, MO, OR, TN, UT, VA, WI
About Micro Therapeutics Inc, Dba Ev3 Neurovascular
Micro Therapeutics Inc, Dba Ev3 Neurovascular has 14 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report