CLASS II ONGOING Device recall · Reported 21 May 2025 · FDA Enforcement Report
Tornado Embolization Microcoil, intended recalled by Cook Incorporated
Cook is recalling Tornado Embolization Microcoil, intended for embolization of selective vessel supply to. The recall was initiated on 17 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1762-2025
- FDA event ID
- 96702
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Apr 2025
- FDA classified
- 14 May 2025
- Reported
- 21 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 17 Apr 2025 | Recall initiated by company | |
| 14 May 2025 | Classified by FDA | +27 days |
| 21 May 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Product as listed by the FDA
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)
Where it was distributed
worldwide - No US distribution.
Questions about this recall
Why was it recalled?
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Which lots are affected?
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
Where was it sold?
worldwide - No US distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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