Recall Z-1762-2025— Cook Incorporated

Name: FDA recall Z-1762-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-17

Class II · Ongoing

Class II FDA medical device recall by Cook Incorporated, initiated 2025-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 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). Reason: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil..

Recalling firm: Cook Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2025-04-17
Firm location: Bloomington, IN, United States

Product description

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)

Reason for recall

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.

Data sourced from openFDA. This site is unofficial and independent of the FDA.