FDA-Device2025-05-21Class II
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)
Cook Incorporated
Hazard
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Sold states
worldwide - No US distribution.
Affected count
2952 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1762-2025Don't want to check this manually?
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