TornadoRecalls & reported problems across all models
Cook Incorporated · 23 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Tornado model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 2
We found 23 models of Tornado by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Mar 10, 2017 and Apr 9, 2026 — classified as 8 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (5 reports).
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Tornado recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 2 of these models · 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 · names 15 of these models · Recall details · FDA record ↗
Most reported Tornado problems
Device problems
- Difficult to Advance5
- Entrapment of Device5
- Migration4
- Adverse Event Without Identified Device or Use Problem3
- Detachment of Device or Device Component3
- Stretched3
- Device Contaminated During Manufacture or Shipping2
- Migration or Expulsion of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Known Impact Or Consequence To Patient6
- Foreign Body In Patient3
- Hepatitis3
- Itching Sensation3
- No Code Available3
- No Consequences Or Impact To Patient3
- No Patient Involvement3
Tornado models
23 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tornado G08261Device, Vascular, for Promoting Embolization2 recalls7 reports
- Tornado G08357Device, Vascular, for Promoting Embolization2 recalls1 report
- Tornado G08259Device, Vascular, for Promoting Embolization1 recall3 reports
- Tornado G08356Device, Vascular, for Promoting Embolization1 recall2 reports
- Tornado G13107Device, Vascular, for Promoting Embolization1 recall1 report
- Tornado G09944Device, Vascular, for Promoting Embolization1 recall0 reports
- Tornado G09945Device, Vascular, for Promoting Embolization1 recall0 reports
- Tornado G12924Device, Vascular, for Promoting Embolization1 recall0 reports
- Tornado G13105Device, Vascular, for Promoting Embolization1 recall0 reports
- Tornado G13106Device, Vascular, for Promoting Embolization1 recall0 reports
- Tornado G13108Device, Vascular, for Promoting Embolization1 recall0 reports
- Tornado G47416Device, Vascular, for Promoting Embolization1 recall0 reports
- Tornado G47417Device, Vascular, for Promoting Embolization1 recall0 reports
- Tornado G47418Device, Vascular, for Promoting Embolization1 recall0 reports
- Tornado G47419Device, Vascular, for Promoting Embolization1 recall0 reports
- Tornado G10415Device, Vascular, for Promoting Embolization3 reports
- Tornado G09215Device, Vascular, for Promoting Embolization2 reports
- Tornado G10413Device, Vascular, for Promoting Embolization2 reports
- Tornado G10416Device, Vascular, for Promoting Embolization2 reports
- Tornado G09216Device, Vascular, for Promoting Embolization1 report
- Tornado G09217Device, Vascular, for Promoting Embolization1 report
- Tornado G10411Device, Vascular, for Promoting Embolization1 report
- Tornado G10412Device, Vascular, for Promoting Embolization1 report
Recent Tornado adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026Difficult to Advance
IT WAS REPORTED THAT A TORNADO PLATINUM EMBOLIZATION MICROCOIL WAS DIFFICULT TO ADVANCE. THE DEVICE WAS REQUIRED FOR A CORONARY ARTERY FISTULA OCCLUSION PROCEDURE. DURING THE PROCEDURE, A MICROCATHETER WAS USED TO PLACE THE COILS. THE FIRST COIL WAS PLACED NORMALLY. THE SECOND COIL FROM THE SAME LOT NUMBER WAS DIFFICULT TO ADVANCE AND SUBSEQUENTLY GOT STUCK IN THE MIDDLE SECTION OF THE CATHETER WITH HALF OF THE COIL EXITING THE DISTAL TIP. THE STUCK COIL WAS REMOVED BY A NEGATIVE PRESSURE VALVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AS REPORTED, 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 24831315 ↗MalfunctionApr 2, 2026Migration
IT WAS REPORTED THAT A TORNADO PLATINUM EMBOLIZATION COIL WAS DIFFICULT TO ADVANCE AND THE COIL MIGRATED INTO A NON-TARGET ARTERY. THE PATIENT WAS UNDERGOING A CORONARY ARTERY FISTULA EMBOLIZATION. DURING INSERTION AND ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER, EXCESSIVE RESISTANCE WAS NOTED. THE COIL BECAME STUCK IN THE MICROCATHETER AND COULD NOT BE ADVANCED DUE TO OBSTRUCTION. WHILE THE COIL WAS STILL INSIDE THE MICROCATHETER, THE CONNECTION BETWEEN THE PUSH ROD AND THE COIL FRACTURED. BEFORE REACHING THE TARGET VESSEL, UNEXPECTED PREMATURE DEPLOYMENT/EXTRUSION OF THE COIL FROM THE DISTAL TIP OF THE CATHETER OCCURRED DURING RELEASE MANIPULATION AND THE COIL MIGRATED INTO THE NON-TARGET PATIENT ARTERY. THE COIL BECAME ENTANGLED WITH THE VESSEL WALL AND WAS CARRIED AWAY BY BLOOD FLOW. THE PUSH ROD WAS THEN WITHDRAWN. THE COIL LOST ITS EMBOLIC EFFECT. A NEW DEVICE WAS OPENED 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 24766017 ↗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 ↗MalfunctionSep 12, 2025Malposition of Device; Malposition of Device
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23040266 ↗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 ↗MalfunctionNov 13, 2023Migration; Migration
IT WAS REPORTED THAT A TORNADO PLATINUM EMBOLIZATION COIL MIGRATED. DURING A HEART CATHETER PROCEDURE, THREE COLLATERAL VESSELS IN THE HEART WERE DISCOVERED. ONE OF THE COLLATERALS WAS DIFFICULT ACCESS; ACCESS WAS ONLY POSSIBLE BY A TRANSJUGULAR APPROACH WITH A GLIDE-CATHETER. THE COLLATERAL SHOWED A STENOSIS OF 4MM (6MM BEFORE AND AFTER). CLOSURE OF THE 4MM COLLATERAL WAS ATTEMPTED WITH A 6MM TORNADO COIL. HOWEVER, DESPITE EXISTING STENOSIS, AFTER THE COIL WAS RELEASED, IT MIGRATED TO THE LEFT VENTRICLE OF THE HEART WITHIN THE MITRAL VALVE TENDON APPARATUS. NO DAMAGE TO THE MITRAL VALVE OR THE CHORDAE TENDINEAE WAS REPORTED. DUE TO THE POSITION OF THE COIL, INTERVENTIONAL EXTRACTION WAS NOT POSSIBLE. THE COIL POSITION IS CURRENTLY STABLE, SO SURGICAL EXTRACTION WAS NOT PERFORMED AS THAT PROCEDURE WOULD HAVE BEEN THE THIRD OPERATION ON EXTRACORPOREAL CIRCULATION FOR THE PATIENT. ALSO, THERE IS NO PLAN TO RETRIEVE THE COIL. THE PATIENT WAS ANTICOAGULATED. AFTER FOUR DAYS OF CLINICAL OBSERVANCE, THE PATIENT WAS DISCHARGED TO OUTPATIENT FOLLOW UP ONCE PER WEEK. AS REPORTED, 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 18125127 ↗MalfunctionApr 11, 2023Unraveled Material; Difficult to Advance; Unraveled Material; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16718586 ↗MalfunctionOct 5, 2022Entrapment of Device; Failure to Eject; Entrapment of Device; Failure to Eject
IT WAS REPORTED THE TORNADO PLATINUM EMBOLIZATION MICROCOIL WAS USED IN CONJUNCTION WITH A SUPPORT CATHETER DURING A CORONARY ANGIOGRAPHY PROCEDURE TO EMBOLIZE A RUPTURED VESSEL. THE 0.039 INCH TAPER TO 0.020 INCH CATHETER WAS FLUSHED BEFORE USE. THE CATHETER WAS DEPLOYED USING A 0.014 INCH WIRE GUIDE. THE PHYSICIAN OBSERVED THE COIL AND WIRE OF THE CATHETER HAD BECOME STUCK TOGETHER DURING DEPLOYMENT. THE WHOLE SYSTEM, COIL AND CATHETER, WERE REMOVED FROM THE PATIENT. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. AS REPORTED, 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 15545361 ↗InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A 61 YEAR OLD, MALE PATIENT UNDERWENT EMBOLIZATION OF THE RIGHT RENAL ARTERY IN PREPARATION FOR A KIDNEY TRANSPLANT. UNDER ANESTHESIA, THE PATIENT RECEIVED MICROSPHERES DISTALLY AND THEN OCCLUSION USING TWO 5/2 TORNADO PLATINUM EMBOLIZATION MICROCOILS, ONE 6/2 TORNADO PLATINUM EMBOLIZATION MICROCOIL, AND ONE 5/3 TORNADO PLATINUM EMBOLIZATION COIL. BEGINNING IN MID MARCH, APPROXIMATELY THREE WEEKS AFTER EMBOLIZATION, THE PATIENT EXPERIENCED WORSENING, DISABLING PRURITUS AND INSOMNIA. ADDITIONALLY, THE PATIENT IS EXPERIENCING COMPLICATED SUBACUTE ANICTERIC CHOLESTATIC HEPATITIS. ADDITIONALLY, A LIST OF THE PATIENT'S TREATMENTS INTRODUCED IN 2022 WAS PROVIDED. THIS LIST INCLUDED TREATMENTS USED DURING EMBOLIZATION: LIDOCAINE; GENERAL ANESTHESIA WITH EPHEDRINE, PROPOFOL, RINGER'S LACTATE, SUFENTANIL, KETOPROFEN, TRAMADOL, MIDAZOLAM, AND DROPERIDOL; NEFOPAM ON 02 AND (B)(6) 2022; METHYLPREDNISOLONE AND CEFAZOLIN ON (B)(6) 2022; SUFENTANIL/DROPERIDOL FROM 01MAR2022 TO 03MAR2022; THEN AT HOME ANALGESIC TREATMENT WITH PARACETAMOL 1G X3/DAY AND PHLOROGLUCINOL, AND TRAMADOL 50MG X 3 / DAY IF PAIN PERSISTS. IT WAS ALSO NOTED THAT AMOXICILLIN WAS GIVEN IN (B)(6) 2021 AND AN INC
Patient problems: Hepatitis; Itching Sensation; Sleep Dysfunction
MAUDE report 15352608 ↗InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A 61 YEAR OLD, MALE PATIENT UNDERWENT EMBOLIZATION OF THE RIGHT RENAL ARTERY IN PREPARATION FOR A KIDNEY TRANSPLANT. UNDER ANESTHESIA, THE PATIENT RECEIVED MICROSPHERES DISTALLY AND THEN OCCLUSION USING TWO 5/2 TORNADO PLATINUM EMBOLIZATION MICROCOILS, ONE 6/2 TORNADO PLATINUM EMBOLIZATION MICROCOIL, AND ONE 5/3 TORNADO PLATINUM EMBOLIZATION COIL. BEGINNING IN MID MARCH, APPROXIMATELY THREE WEEKS AFTER EMBOLIZATION, THE PATIENT EXPERIENCED WORSENING, DISABLING PRURITUS AND INSOMNIA. ADDITIONALLY, THE PATIENT IS EXPERIENCING COMPLICATED SUBACUTE ANICTERIC CHOLESTATIC HEPATITIS. ADDITIONALLY, A LIST OF THE PATIENT'S TREATMENTS INTRODUCED IN 2022 WAS PROVIDED. THIS LIST INCLUDED TREATMENTS USED DURING EMBOLIZATION: LIDOCAINE; GENERAL ANESTHESIA WITH EPHEDRINE, PROPOFOL, RINGER'S LACTATE, SUFENTANIL, KETOPROFEN, TRAMADOL, MIDAZOLAM, AND DROPERIDOL; NEFOPAM ON (B)(6) 2022; METHYLPREDNISOLONE AND CEFAZOLIN ON (B)(6) 2022; SUFENTANIL/DROPERIDOL FROM (B)(6) 2022; THEN AT HOME ANALGESIC TREATMENT WITH PARACETAMOL 1G X3/DAY AND PHLOROGLUCINOL, AND TRAMADOL 50MG X 3 / DAY IF PAIN PERSISTS. IT WAS ALSO NOTED THAT AMOXICILLIN WAS GIVEN IN APRIL 2021 AND AN INCREASE IN ALKALINE P
Patient problems: Hepatitis; Itching Sensation; Sleep Dysfunction
MAUDE report 15352596 ↗InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A 61 YEAR OLD, MALE PATIENT UNDERWENT EMBOLIZATION OF THE RIGHT RENAL ARTERY IN PREPARATION FOR A KIDNEY TRANSPLANT. UNDER ANESTHESIA, THE PATIENT RECEIVED MICROSPHERES DISTALLY AND THEN OCCLUSION USING TWO 5/2 TORNADO PLATINUM EMBOLIZATION MICROCOILS, ONE 6/2 TORNADO PLATINUM EMBOLIZATION MICROCOIL, AND ONE 5/3 TORNADO PLATINUM EMBOLIZATION COIL. BEGINNING IN MID MARCH, APPROXIMATELY THREE WEEKS AFTER EMBOLIZATION, THE PATIENT EXPERIENCED WORSENING, DISABLING PRURITUS AND INSOMNIA. ADDITIONALLY, THE PATIENT IS EXPERIENCING COMPLICATED SUBACUTE ANICTERIC CHOLESTATIC HEPATITIS. ADDITIONALLY, A LIST OF THE PATIENT'S TREATMENTS INTRODUCED IN 2022 WAS PROVIDED. THIS LIST INCLUDED TREATMENTS USED DURING EMBOLIZATION: LIDOCAINE; GENERAL ANESTHESIA WITH EPHEDRINE, PROPOFOL, RINGER'S LACTATE, SUFENTANIL, KETOPROFEN, TRAMADOL, MIDAZOLAM, AND DROPERIDOL; NEFOPAM ON (B)(6); METHYLPREDNISOLONE AND CEFAZOLIN ON (B)(6) 2022; SUFENTANIL/DROPERIDOL FROM (B)(6); THEN AT HOME ANALGESIC TREATMENT WITH PARACETAMOL 1G X3/DAY AND PHLOROGLUCINOL, AND TRAMADOL 50MG X 3 / DAY IF PAIN PERSISTS. IT WAS ALSO NOTED THAT AMOXICILLIN WAS GIVEN IN (B)(6) 2021 AND AN INCREASE IN ALKALINE PHOSPHATAS
Patient problems: Hepatitis; Itching Sensation; Sleep Dysfunction
MAUDE report 15352334 ↗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 ↗MalfunctionMay 14, 2020Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance
ADDITIONAL INFORMATION RECEIVED 17MAY2020 INDICATED THE PHYSICIAN TOOK OUT THE CATHETER OUT OF THE PATIENT'S BODY. ANOTHER SIMILAR CATHETER WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10055963 ↗InjuryApr 28, 2020Migration; Migration
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Code Available
MAUDE report 10006221 ↗MalfunctionApr 29, 2019Migration; Migration
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8560387 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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