Tornado G10412Recalls & reported problems
Cook Incorporated · Tornado Embolization Coil · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002104129), received between Mar 10, 2017 and Mar 10, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- Foreign Body In Patient1
- Hematuria1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
THE CONSUMER / PATIENT REPORTED UNDERGOING A VENOGRAM PROCEDURE WITH EMBOLIZATION ON (B)(6) 2015 FOR AN UNSPECIFIED REASON. THE PATIENT ALLEGED THAT SHE RETURNED FOR A SECOND PROCEDURE ON (B)(6) 2015 AND A THIRD PROCEDURE ON (B)(6) 2015. THE SPECIFIC ANATOMICAL SITE OF EMBOLIZATION FOR EACH PROCEDURE WAS NOT PROVIDED. THE PATIENT FURTHER ALLEGED THAT SHE UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN ON AN UNKNOWN DATE. IT WAS STATED THE SCAN REVEALED THAT ONE (1) COIL MIGRATED AND EMBEDDED INTO THE "RIGHT SEPTUM" OF HER HEART. THE PATIENT ALLEGES THAT SHE IS INTERNALLY BLEEDING AND THAT THERE IS BLOOD IN HER STOOL AND URINE. THE SPECIFIC DIAGNOSIS AND ETIOLOGY OF THE ALLEGED HEMATURIA WAS NOT PROVIDED. THE PATIENT DID NOT STATE IF THE REPORTED BLOOD IN HER STOOL WAS MELENA FROM UPPER GI BLEEDING OR HEMATOCHEZIA ORIGINATING FROM LOWER GI BLEEDING. NO MEDICAL RECORDS OR LISTING OF CURRENT MEDICATIONS WERE PROVIDED. THE CAUSAL RELATIONSHIP BETWEEN THE DEVICE ALLEGEDLY EMBEDDED IN THE "RIGHT SEPTUM' OF THE HEART AND THE REPORTED BLOOD IN THE STOOL AND URINE WAS NOT PROVIDED. THE PATIENT REPORTS THAT SHE WAS SCHEDULED FOR A REPEAT CT SCAN ON (B)(6) 2017; NO INFORMATION OR RESULTS OF THIS SC
Patient problems: Foreign Body In Patient; Hematuria; No Code Available
MAUDE report 6396056 ↗
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
- 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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