Recall archive / FDA device enforcement
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations a... — FDA record Z-1762-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 17, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
- Classification
- Class II
- Recalling firm
- Cook Incorporated
- Quantity
- 2952 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1762-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
worldwide - No US distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 21, 2025
- Recall initiation date
- Apr 17, 2025
- Center classification date
- May 14, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.