Tornado G08357Recalls & 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
2 open recalls name 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
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002083578), received between Aug 7, 2020 and Aug 7, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).
2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Apr 17, 2025Open, Classified
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Z-1762-2025 · Root cause: Process control · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A TORNADO PLATINUM EMBOLIZATION MICROCOIL. WHEN THE PACKAGE WAS OPENED, A HAIR-LIKE FIBER WAS FOUND INSIDE THE PACKAGING. THE DEVICE DID NOT MAKE PATIENT CONTACT AND A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10379731 ↗
Other Device, Vascular, for Promoting Embolization devices
- POD RBYPOD8-APenumbra, Inc. · Device, Vascular, For Promoting Embolization195 reports
- 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
- 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 · each recall links to the FDA recall notice
- 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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