Tornado G09215Recalls & reported problems
Cook Incorporated · Tornado Embolization Microcoil · Class 2 · Implant
All models of Tornado (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002092150), received between Feb 27, 2018 and Dec 7, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Unraveled Material1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 7, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED FOREIGN MATTER WAS FOUND IN THE PEEL-AWAY PACKAGING FOR A TORNADO PLATINUM EMBOLIZATION MICROCOIL. THE FOREIGN MATTER WAS DISCOVERED AT A THIRD PARTY DISTRIBUTOR AND DID NOT REACH A USER FACILITY.
Patient problems: No Patient Involvement
MAUDE report 8143038 ↗MalfunctionFeb 27, 2018Unraveled Material; Unraveled Material
THE INTERNATIONAL CUSTOMER REPORTED THAT, AFTER THE SUCCESSFUL RELEASE OF THE FIRST TORNADO PLATINUM EMBOLIZATION MICROCOIL, THE SECOND COIL COULD NOT BE RELEASED AS IT BECAME STUCK IN THE FRONT END OF THE CATHETER. THE USER ATTEMPTED TO RETRACT THE MICROCOIL, BUT WAS UNSUCCESSFUL. THE CATHETER ULTIMATELY HAD TO BE WITHDRAWN FROM THE BLOOD VESSEL, AT WHICH POINT IT WAS DISCOVERED THAT THE WIRE GUIDE WAS ALSO STUCK IN THE MICROCOIL. THE USER FINALLY CHANGED TO ANOTHER DEVICE ENTIRELY TO CONTINUE THE PROCEDURE, WITH NO FURTHER ISSUES REPORTED. DURING INVESTIGATION THE IMAGES PROVIDED INDICATED THE COIL HAD ELONGATED. THE COMPLAINT PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7301782 ↗
Other Device, Vascular, for Promoting Embolization devices
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- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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