Tornado G10416Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002104167), received between Aug 14, 2017 and Nov 13, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 14, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING EMBOLIZATION OF SIDE BRANCH VEIN USING A TORNADO PLATINUM EMBOLIZATION COIL. THE COIL REPORTEDLY MIGRATED TO CEPHALIC VEIN AS AN UNSPECIFIED TIME DURING THE PROCEDURE. THE CUSTOMER RECHECKED THE POSITION OF THE COIL AT THE CONCLUSION OF THE ANGIOPLASTY PORTION AND NOTED THAT IT FURTHER MIGRATED TO THE RIGHT VENTRICLE. THE ACTIONS TAKEN BY THE CLINICAL STAFF AT THIS POINT IN THE PROCEDURE ARE NOT KNOWN NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADDITIONAL INFORMATION. THE PRODUCT INSERT THAT ACCOMPANIES EACH DEVICE WARNS THAT "POSITIONING OF EMBOLIZATION COILS SHOULD BE DONE WITH PARTICULAR CARE. COILS SHOULD NOT BE LEFT TOO CLOSE TO THE INLETS OF ARTERIES AND SHOULD BE INTERMESHED WITH PREVIOUSLY PLACED COILS IF POSSIBLE. A MINIMAL BUT SUFFICIENT ARTERIAL BLOOD FLOW SHOULD REMAIN TO HOLD THE COILS AGAINST THE PREVIOUSLY PLACED COILS UNTIL A SOLID CLOT ENSURES PERMANENT FIXATION. THE PURPOSE OF THESE SUGGESTIONS IS TO MINIMIZE THE POSSIBILITY OF LOOSE COILS BECOMING DISLODGED AND OBSTRUCTING A NORMAL AND ESSENTIAL ARTERIAL CHANNEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 6791293 ↗