Tornado G09217Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002092174), received between Jun 27, 2024 and Jun 27, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2024Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT A TORNADO PLATINUM EMBOLIZATION MICROCOIL WAS DIFFICULT TO DEPLOY. THE DEVICE WAS REQUIRED FOR ENDOVASCULAR ANEURYSM REPAIR OF THE INTERNAL ILIAC ARTERY OF AN 81-YEAR-OLD MALE PATIENT. DURING THE PROCEDURE, COOK NESTER COILS WERE PLACED IN THE DISTAL PORTION OF THE ANEURYSM. DUE TO THE PATIENT'S ANATOMY, IT WAS DIFFICULT TO MANEUVER AROUND THE TORTUOUS ARTERY. A COMPETITOR'S RETRACTABLE COILS WERE ATTEMPTED TO BE PLACED THREE TIMES UNSUCCESSFULLY. THEN, THE COOK TORNADO COIL WAS ADVANCED THROUGH A COMPETITOR'S CATHETER, BUT IT DID NOT FULLY DEPLOY OUT OF THE CATHETER. THE COIL WAS SUCCESSFULLY RETRIEVED WITH THE CATHETER AND SHEATH BEFORE IT FULLY DEPLOYED FROM THE CATHETER. A SECOND COOK TORNADO COIL WAS OBTAINED AND WAS SUCCESSFULLY DEPLOYED ON THE SECOND ATTEMPT WITH SOME EFFORT AND INVOLVEMENT OF A SENIOR PHYSICIAN. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THIS REPORT WILL CAPTURE THE FIRST TORNADO COIL THAT WAS REMOVED FROM THE PATIENT. THE SECOND TORNADO COIL WILL BE CAPTURED IN A REPORT WITH PATIENT IDENTIFIER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629801 ↗
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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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