AVIATOR 4246020WRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032005903), received between Aug 28, 2017 and Feb 2, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2023Deflation Problem; Deflation Problem

  AS REPORTED, WHEN THE FILLING BALLOON OF AN AVIATOR PLUS .014 6.0X20 142CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS DEFLATED, IT WAS FOUND TO BE DIFFICULT TO DEFLATE, AND IT TOOK A LONG TIME TO REMOVE IT. THE WITHDRAWAL DIFFICULTY WAS ENCOUNTERED WHEN WITHDRAWING FROM THE GUIDE/SHEATH. ONCE IT WAS REMOVED FROM THE GUIDE IT WAS NOTICED THAT THE DELIVERY ROD WAS KINKED. THERE WAS NO REPORTED PATIENT INJURY. THE AVIATOR PLUS WAS USED BY THE SURGEON TO PRE-EXPAND THE LESION AFTER AN ANGIOGUARD WAS RELEASED INTO PLACE. THE INTENDED PROCEDURE WAS REPORTED TO BE BALLOON DILATION OF THE LEFT INTERNAL CAROTID ARTERY PLUS STENTING. THE LESION CALCIFICATION WAS MODERATE, WITH SEVERE TORTUOSITY AND SEVENTY PER-CENT STENOSIS. THE DEVICE WAS NOT USED FOR A TOTAL CHRONIC OCCLUSION (CTO). THERE WAS NEITHER DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, NOR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY MAINTAINING NEGATIVE PRESSURE. THE SAME INDEFLATOR WAS SUCCESSFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287521 ↗
• MalfunctionJun 21, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A AVIATOR PLUS .014 6.0X20 RUPTURED. IT WAS REPLACED WITH ANOTHER SAME SIZED UNKNOWN BALLOON CATHETER AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT 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 OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED PER THE IFU AND WAS PREPPED NORMALLY. THE PROCEDURE BEING PERFORMED WAS A BALLOON PULMONARY ANGIOPLASTY (BPA). THE BALLOON DID NOT RUPTURE WHILE IN A STENT. 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 GUIDE CATHETER. THE DEVICE ADVANCED THROUGH THE VESSEL WITHOUT DIFFICULTY. THE CATHETER WAS NOTED TO HAVE BEEN IN AN ACUTE BEND; HOWEVER, IT WAS NOTED THE DEVICE WAS NEVER KINKED WHILE BEING USED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT (IN ONE PIECE). THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14753159 ↗
• MalfunctionOct 25, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE AVIATOR PLUS .014 6.0X20 142CM BALLOON RUPTURED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE INTENDED PROCEDURE WAS A PERIPHERAL INTERVENTIONAL. THE LESION WAS MODERATELY CALCIFIED. THERE WAS MODERATE VESSEL TORTUOSITY. 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 PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). AN INDEFLATOR DEVICE WAS USED FOR INFLATION. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON DID NOT INFLATE NORMALLY. LEAKAGE WAS NOTED FROM THE BALLOON. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE PROCEDURE WAS COMPLETED USING OTHER PRODUCTS. THE PRODUCT WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689400 ↗
• MalfunctionOct 4, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE 014¿ 6.0 X 20 X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST AND DID NOT BLOW UNDER PRESSURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY WHILE REMOVING THE DEVICE FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING THE STYLET AND ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS, OR ANY OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE TARGET LESION WAS NOTED TO HAVE A LITTLE CALCIFICATION AND THE VESSEL HAD SOME TORTUOSITY. THE DEVICE WAS NOT BEING USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE INFLATION DEVICE WAS FILLED WITH A CONTRAST/SALINE RATIO OF 1:1 AND THAT SAME INFLATION DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES. NO RESISTANCE/FRICTION WAS NOTED WHILE ADVANCING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND THERE WAS NO RESISTANCE EXPERIENCED WHILE ADVANCING THROUGH THE GUIDE CATHETER. THE BALLOON CATHETER WAS ADVANCED THROUGH THE VESSEL AND CROSSED THE LESION WITHOUT DIFFICULTY. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572750 ↗
• MalfunctionDec 23, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING A CAROTID ARTERY STENT IMPLANTATION, A .014 6.0X20 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA)BALLOON CATHETER WAS ATTEMPTED TO BE USED FOR POST-DILATATION BUT IT WAS FOUND THAT THERE WAS A PINHOLE RUPTURE AT THE TIP OF THE BALLOON. THE HOLE WAS NOTED AFTER THE PACKAGING WAS OPENED, AND THE DEVICE WAS FLUSHED. THE DEVICE HAD BEEN CONNECTED TO THE NEGATIVE PRESSURE PUMP. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DIFFICULTIES REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS, THE PRODUCT FROM THE HOOP, OR THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO USE. IOPAMIDOL CONTRAST MEDIA WAS USED WITH A1:1, CONTRAST TO SALINE RATIO. A NON-CORDIS INDEFLATOR WAS USED AND IT WAS USED SUCCESSFULLY WITH THE OTHER DEVICES. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT WERE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511506 ↗
• MalfunctionApr 25, 2019Leak/Splash; Leak/Splash

  BEFORE USE, THERE WAS LEAKAGE FROM THE AVIATOR PLUS .014 6.0X20 142CM BALLOON. THERE WERE NO REPORTED PATIENT INJURIES. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8551990 ↗
• MalfunctionJun 22, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE, IT WAS REPORTED THAT THE AVIATOR PLUS BALLOON CATHETER WAS DELIVERED AND INFLATED. HOWEVER, THE BALLOON CATHETER RUPTURED AT FOUR ATMOSPHERE (WITHIN ITS NOMINAL PRESSURE). THERE WAS NO PATIENT INJURY. THE RUPTURE WAS CONFIRMED BY LEAKAGE OF CONTRAST MEDIA. THE LESION IS THE ILIAC ARTERY. A UNKNOWN GUIDEWIRE CROSSED THE LESION. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7629448 ↗
• MalfunctionDec 11, 2017Burst Container or Vessel; Burst Container or Vessel

  DURING THE USE OF THE AVIATOR PLUS BALLOON CATHETER, THE BALLOON WAS DELIVERED TO THE LESION FOR INFLATION. HOWEVER IT RUPTURED DUE TO CALCIFICATION. IT WAS UNKNOWN HOW THE PROCEDURE COMPLETED HOWEVER, THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE PULMONARY ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS WAS UNKNOWN. THE LESION WAS HEAVILY CALCIFIED. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7104367 ↗
• MalfunctionAug 28, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE AVIATOR PLUS BALLOON CATHETER WAS DELIVERED TO INFLATE HOWEVER, IT RUPTURED. THEREFORE IT WAS REPLACED WITH A NEW AVIATOR PLUS (5 MM) AND THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS THE PULMONARY ARTERY. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE PRODUCT WAS CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6825491 ↗