Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tornado Embolization Microcoil Recalled by Cook Incorporated Due to Cook Medical identified that devices from the affected...
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 Cook Incorporated directly.
Affected Products
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)
Quantity: 2952 units
Why Was This Recalled?
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Where Was This Sold?
worldwide - No US distribution.
About Cook Incorporated
Cook Incorporated has 64 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report