AVIATOR 4245515WRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032005859), received between Apr 26, 2019 and Feb 4, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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.

• MalfunctionFeb 4, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 0.014¿ 5.5MM X 15MM X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED; HOWEVER, BALLOON LEAKAGE OCCURRED AT 6 ATMOSPHERIC PRESSURE (ATM). THEREFORE, IT WAS REPLACED WITH A NEW BALLOON CATHETER (UNKNOWN) AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A RENAL ARTERY STENOSIS (RAS) CASE. THE LESION HAD LITTLE CALCIFICATION, NO TORTUOSITY, AND 90% STENOSIS. THE DEVICE USED NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS NOR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). IOMERON CONTRAST MEDIA WAS USED. THE CONTRAST TO SALINE RATIO WAS 2:1. A NON-CORDIS INFLATION DEVICE WAS USED. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279717 ↗
• MalfunctionApr 26, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN AVIATOR PLUS BALLOON CATHETER (.014 5.5X15 142CM) WAS DELIVERED TO THE LESION IN THE RENAL ARTERY, HOWEVER, IT RUPTURED AT 14 ATMOSPHERES (ATMS) DUE TO SEVERE CALCIFICATION. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8555614 ↗