Tornado G13107Recalls & reported problems
Cook Incorporated · Tornado Embolization Microcoil · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002131071), received between Mar 2, 2026 and Mar 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 5, 2022Open, Classified
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Z-1242-2022 · Root cause: Under Investigation by firm · FDA record ↗
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.
MalfunctionMar 2, 2026Difficult to Advance
IT WAS REPORTED THAT A TORNADO PLATINUM EMBOLIZATION MICROCOIL WAS DIFFICULT TO ADVANCE THROUGH A COMPETITOR CATHETER DURING AN UNKNOWN PROCEDURE FOR AN UNKNOWN PATIENT. THE 4FR CATHETER WAS FLUSHED, AND DURING ATTEMPTED DELIVERY OF THE COIL, RESISTANCE WAS ENCOUNTERED. A PORTION OF THE COIL EXITED THE DISTAL TIP OF THE CATHETER BUT WAS UNABLE TO BE FULLY DEPLOYED. A NEW COMPETITOR CATHETER AND COIL WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24483348 ↗
Other Device, Vascular, for Promoting Embolization devices
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- CEREPAKTM MDH1Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 recall72 reports
- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- 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
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.