AVIATOR 4247015WRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032005934), received between Apr 25, 2019 and Jan 13, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE AVIATOR PLUS WAS USED. HOWEVER, THE BALLOON RUPTURED AT 8 ATM. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER SAME SIZED AVIATOR PLUS AND ADDITIONAL INFLATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE RENAL ARTERY. AN UNKNOWN GUIDEWIRE WAS INSERTED. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, STYLET, OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS, OR ANY OTHER DAMAGES NOTED PRIOR TO INSERTING INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR WHILE INSERTING THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON THROUGH THE VESSEL AND NONE NOTED WHILE CROSSING THE LESION. THE LESION HAS MILD CALCIFICATION AND THE VESSEL HAD MILD TORTUOSITY. THE LESION HAD A 90% STENOSIS. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158112 ↗
• MalfunctionNov 24, 2020Material Rupture; Material Rupture

  A 0.014¿ 7.0MM X 15MM X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED DURING ITS THIRD INFLATION AT 12 ATMOSPHERES (ATM) DURING A BALLOON PULMONARY ANGIOPLASTY PROCEDURE. IT WAS REPLACED WITH A NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE AVIATOR WAS INFLATED AT 8 ATM FOR 10 MINUTES DURING THE INITIAL INFLATION AND AT 10 ATM FOR 10 MINUTES DURING ITS SECOND INFLATION. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS DUE TO THE HOSPITAL REGULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10897743 ↗
• MalfunctionApr 25, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 7.0X15 AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS DELIVERED TO THE LESION AND ON THE SECOND INFLATION, THE BALLOON RUPTURED AT TWELVE ATMOSPHERES (ATM), WHICH WAS CONFIRMED BY THE BACK-FLOW. NO PATIENT INJURY WAS REPORTED. THE AVIATOR PLUS PTA BC WAS DELIVERED TO THE LESION AND INFLATED AT TEN ATM DURING IT¿S INITIAL INFLATION WITHOUT ANY ISSUES, HOWEVER THE LESION WAS NOT INFLATED ENOUGH. THE DEVICE WAS REPLACED WITH A NEW UNKNOWN BC AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8549982 ↗