Tornado Embolization Microcoil — Class II medical device recall Z-1762-2025
Ongoing recall by Cook Incorporated, reported 2025-05-21. Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolizat
| Recall number | Z-1762-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2025-04-17 |
| Classified | 2025-05-14 |
| Reported by FDA | 2025-05-21 |
| Quantity | 2,952 units |
| UPC / GTIN / UDI-DI | 00827002082618, 00827002083578, 00827002131026 |
| Lot numbers | 16178639, 16181782, 16181783, 16181784, 16183145, 16183146, 16186101, 16188094, 16188095, 16194351, 16196532, 16196533, 16196534, 16196535, 16197247, 16197248, 16197249, 16197250, 16197251, 16197252, 16197253, 16204238, 16233647, 16233648, 16233649, MWCE-18S-3/2-TORNADO-081800, MWCE-18S-4/2-TORNADO, NS16178638, NS16188093, NS16192163, NS16199061, NS16233646 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1762-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.