[pending] Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenou
Pending LLM rewrite. Source: FDA_DEVICE Z-1762-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
The recalled product
- 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)
- Manufacturer
- Cook Incorporated
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- MWCE-18S-3/2-TORNADO
- UDI-DI: 00827002082618
- 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
Distribution scope not specified by the agency.
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