Tornado G08356Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002083561), received between Sep 2, 2022 and Oct 5, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

1 FDA recall record name this device's identifier, 1 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 (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 ↗