FDA Medical devices recall · May 21, 2025

Tornado Embolization Microcoil, intended for embolization of selective… recall

Recall number: Z-1762-2025
Date: May 21, 2025 (initiated April 17, 2025)
Company / brand: Cook Incorporated
750 N Daniels Way, Bloomington, IN, United States
Category: Medical devices › Class II
Classification: Class II
Status: Ongoing
Units affected: 2952 units
Initiated by: Voluntary: Firm initiated

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)

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

MWCE-18S-3/2-TORNADO, UDI-DI: 00827002082618, Lot Numbers: 16183145 16183146 16194351 16196532 16196533 16197253 NS16188093 NS16192163 16196534 16196535 16197247 16197248 16197249 16197250 16197251 16197252 16204238 NS16199061 16233647 16233648 16233649 NS16233646; MWCE-18S-4/2-TORNADO, UDI-DI: 00827002083578, Lot Numbers: 16178639 16181782 16181783 16181784 16186101 NS16178638; MWCE-18S-3/2-TORNADO-081800, UDI-DI: 00827002131026, Lot Numbers: 16188094 16188095

Distribution

worldwide - No US distribution.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1762-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.