FDA recall Z-1762-2025

Cook Incorporated · Class II · device

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 for recall

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

Distribution

worldwide - No US distribution.

Key facts

Status: Ongoing
Initiation date: 2025-04-17
Report date: 2025-05-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1762-2025