Tornado G08259Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002082595), received between Apr 20, 2017 and Sep 2, 2022 — classified as 1 injury, 2 malfunctions.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 30, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  INTERNATIONAL CUSTOMER REPORTED THAT THE MICROCOIL DROPPED FROM THE CANNULA WHEN THEY OPENED THE PACKAGE. THERE WAS NO PATIENT CONTACT, ACCORDINGLY NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE WAS RECEIVED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6597630 ↗
• MalfunctionApr 20, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  INTERNATIONAL CUSTOMER REPORTED THAT THE TORNADO PLATINUM EMBOLIZATION MICROCOIL DROPPED FROM THE CANNULA WHEN THEY OPENED THE PACKAGE. THE DEVICE WAS INTENDED TO BE USED FOR AN UNSPECIFIED VESSEL EMBOLIZATION PROCEDURE. THE EVENT OCCURRED PRIOR TO USE. A REPLACEMENT DEVICE WAS OBTAINED. THERE ARE NO ADVERSE PATIENT CONSEQUENCES. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6506921 ↗