AVIATOR 4244015WRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032005736), received between Mar 30, 2018 and Jun 7, 2024 — 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.

• MalfunctionJun 7, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE .014 4.0X15 AVIATOR PLUS WAS USED. HOWEVER, IT RUPTURED AT ITS NOMINAL PRESSURE. THEREFORE, IT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE PRODUCT WAS REMOVED INTACT FROM THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE 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 THE DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE LESION WAS IN THE RENAL ARTERY WHICH HAD A 80% STENOSIS. THE LESION WAS NOTED TO HAVE MODERATE CALCIFICATION WITH MILD VESSEL TORTUOSITY. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO RESISTANCE/ FRICTION WHILE INSERTING THE BALLOON THROUGH THE UNKNOWN GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491918 ↗
• MalfunctionNov 20, 2019Material Rupture; Material Rupture

  AS REPORTED, THE .014 4.0 X 15 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) RUPTURED AT TWELVE ATMOSPHERES (12ATM) DURING ITS INITIAL INFLATION. THE PROCEDURE WAS THEREFORE COMPLETED USING ANOTHER BALLOON CATHETER AND A CUTTING CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS AT THE RIGHT POPLITEAL ARTERY WHICH NOTED TO HAVE SEVERE CALCIFICATION AND EXTREMELY SHORT SEVERE STENOSIS. A CONTRALATERAL APPROACH WAS MADE USING A NON-CORDIS GUIDING CATHETER. A NON-CORDIS GUIDEWIRE HAD CROSSED THE LESION. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY MISTAKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349777 ↗
• MalfunctionMar 30, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE, IT WAS REPORTED THAT THE AVIATOR PLUS BALLOON CATHETER RUPTURED AT TEN ATMOSPHERE (10 ATM). THERE WAS NO PATIENT INJURY. THE AVIATOR BALLOON WAS REPLACED WITH A NEW UNKNOWN CUTTING BALLOON CATHETER AND THE PROCEDURE WAS COMPLETE SUCCESSFULLY. THE LESION WAS THE LEFT POPLITEAL ARTERY. THE LESION HAD HEAVY STENOSIS AND SEEMED TO BE HEAVILY CALCIFIED. A 6F NON CORDIS SHEATH WAS INSERTED TO MAKE AN IPSILATERAL APPROACH AND A NON CORDIS GUIDEWIRE CROSSED THE LESION. THEN AN AVIATOR PLUS WAS DELIVERED TO THE LESION AND INFLATED. THE LESION WAS THE LEFT POPLITEAL ARTERY. THE LESION HAD HEAVY STENOSIS AND SEEMED TO BE HEAVILY CALCIFIED. THE DEVICE HAS BEEN ALREADY DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7384785 ↗