Tornado G08261Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002082618), received between Sep 7, 2017 and Apr 9, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

2. 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

Recent adverse event reports

The 7 most recent of 7 reports, 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 ↗
• 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 21, 2018Break; Positioning Failure; Sticking

  IT WAS REPORTED THAT THE EMBOLIZATION MICRO COIL WAS STUCK OR NOT PRESENT IN THE DELIVERY SYSTEM AND NO COIL COULD BE DEPLOYED. HOWEVER, IT WAS FURTHER NOTED THAT ONE HUB WAS BROKEN FROM THE LOADING CARTRIDGE AND ONE HUB WAS BROKEN INTO PIECES AT THE PROXIMAL END OF THE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7626712 ↗
• MalfunctionJun 21, 2018Entrapment of Device; Stretched

  THE COMPLAINANT REPORTED THAT THE EMBOLIZATION MICRO COIL WAS STUCK AT THE TIP OF THE MICRO CATHETER. IT WAS FURTHER NOTED THAT THE COIL WAS STRETCHED. A NEW DEVICE WAS USED TO FINISH THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7626433 ↗
• MalfunctionJun 21, 2018Entrapment of Device; Stretched

  THE COMPLAINANT REPORTED THAT THE TORNADO PLATINUM EMBOLIZATION MICROCOIL WAS STUCK IN THE END OF THE MICROCATHETER. IT WAS FURTHER NOTED THAT THE COIL WAS STRETCHED. THE PROCEDURE WAS COMPLETED BY USING A NEW DEVICE, AND THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7624692 ↗
• InjurySep 7, 2017Fracture; Fracture

  IT WAS REPORTED BY THE INTERNATIONAL CUSTOMER THAT, DURING THE INTRODUCTION OF A TORNADO PLATINUM EMBOLIZATION MICROCOIL INTO THE PATIENT, THERE WAS A FEELING OF RESISTANCE NEARBY THE AREA IN WHICH THE COIL WAS GOING TO BE PLACED. AS PRECAUTION, THE OPERATOR REMOVED THE DEVICE FROM THE PATIENT AND EXAMINED IT. IT WAS NOTED THAT THE COIL WAS BROKEN INTO SEVERAL PIECES. THERE WERE REPORTEDLY NO PATIENT ADVERSE EFFECTS; ALTHOUGH THERE WAS AN EXTENSION OF THE PROCEDURE TIME AS A RESULT, NO ADDITIONAL ANESTHESIA WAS REQUIRED. ALL PIECES OF THE COIL WERE REPORTEDLY RETRIEVED. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE ARE NOT FULLY KNOWN. THE CUSTOMER HAS NOT CONFIRMED WHETHER OR NOT THE PRODUCT WILL BE RETURNING.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6849626 ↗