Tornado G10415Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002104150), received between Mar 31, 2017 and Apr 11, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryMar 31, 2017Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  (B)(4) STATES: DURING AN INTERVENTIONAL RADIOLOGY PROCEDURE, A 5MM TITANIUM VASCULAR COIL INTENDED FOR ONE VESSEL MIGRATED OFF THE CATHETER AND FLOATED TO A SIDE BRANCH OF ANOTHER VESSEL. THE COIL LODGED IN THE UNINTENDED VESSEL AND COULD NOT BE REMOVED. CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING AN UNSPECIFIED INTERVENTIONAL RADIOLOGY PROCEDURE WITH INTENDED VESSEL EMBOLIZATION. A TORNADO PLATINUM EMBOLIZATION COIL WAS DEPLOYED. THE COIL REPORTEDLY MIGRATED OFF THE CATHETER AND LODGED IN ANOTHER UNINTENDED VESSEL. THE SPECIFIC EMBOLIZATION VESSEL AND SITE WHERE THE COIL MIGRATED AND LODGED IS NOT KNOWN. THE PHYSICIAN WAS NOT ABLE TO DISLODGE AND REMOVE THE COIL. A NEW COIL WAS DEPLOYED TO THE INTENDED EMBOLIZATION SITE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 6449044 ↗