AVIATOR 4247020WRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032005941), received between Mar 8, 2019 and Nov 5, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE .014 7.0X20 142CM AVIATOR PLUS WAS USED BUT RUPTURED. THE PROCEDURE WAS BALLOON PULMONARY ANGIOPLASTY (BPA). THE LESION HAD A LITTLE CALCIFICATION. THE DEVICE WAS REPLACED BY A SMALLER AVIATOR PLUS BALLOON CATHETER AND THE94 PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE VESSEL TORTUOSITY WAS LITTLE WITH 99% STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY IN REMOVING THE PRODUCT FROM THE HOOP AND 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 PREP AS PER THE INSTRUCTION FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAINING NEGATIVE PRESSURE). THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND THROUGH THE GUIDE CATHETER. THE CATHETER WAS IN AN ACUTE BEND. THE DEVICE HAD TO PASS THROUGH A PREVIOUSLY PLACED STENT. THE MAXIMUM INFLATION PRESSURE WAS 8 ATMOSPHERES (ATM). THE B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281386 ↗
• MalfunctionSep 16, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN AVIATOR PLUS .014 7.0 X 20 142 CM WAS INSERTED FOR POST STENTING; HOWEVER, IT RUPTURED AT 5 ATMOSPHERES (ATM). THEREFORE, IT WAS REPLACED WITH A NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY REPORTED. THE DEVICE WAS DISCARDED BY MISTAKE. THIS WAS THIS WAS A CAROTID ARTERY STENTING (CAS) CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9071353 ↗
• MalfunctionApr 22, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN AVIATOR PLUS .014 7.0X20 142CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS DELIVERED TO THE LESION, BUT IT RUPTURED WHILE IT WAS INFLATED. THERE WAS NO REPORTED PATIENT INJURY. A NON-CORDIS HIGH PRESSURE BC WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN COMMENTED THAT THE ISSUE MIGHT HAVE OCCURRED DUE TO SEVERE CALCIFICATION. THE DEVICE WAS DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535702 ↗
• MalfunctionMar 26, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN AVIATOR PLUS (.014 7.0X20 142CM) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) BALLOON RUPTURED DUE TO THE CALCIFIED VESSEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8451710 ↗
• MalfunctionMar 8, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, AN AVIATOR PLUS (.014 7.0 X 20 142CM) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS INSERTED FOR A POST DILATION AFTER A SMART STENT (8X40MM) WAS IMPLANTED, HOWEVER IT RUPTURED AT APPROXIMATELY 6 ATMOSPHERES (ATM). THE BALLOON SEEMED TO BE DEFLATED GRADUALLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION FOR THE EVT CASE WAS THE EXTERNAL ILIAC ARTERY WHICH HAD STENOSIS. IT WAS REPLACED WITH A SABER RX BC OF THE SAME SIZE AND THE PROCEDURE WAS COMPLETED. THERE WAS A LITTLE LESION CALCIFICATION. THERE WAS NOT ANY VESSEL TORTUOSITY. THERE WAS NOT ANY VESSEL ANGULATION. THE DEVICE WAS NOT BEING USED TO TREAT CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOT ANY DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THERE WAS NOT ANY DIFFICULTY REMOVING THE PROTECTIVE BALLOON. THERE WAS NOT ANY DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NOT KINKS OR OTHER DAMAGE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE CONTRAST TO SALINE RATIO WAS 1:1. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH THE OTHER DEVI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8403730 ↗