AVIATOR 4245040WRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032005842), received between Jul 15, 2019 and Apr 10, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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.

• MalfunctionApr 10, 2025Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLON OF A 5MM X 40MM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 5 ATMOSPHERES (ATM). A 4MM X 40MM AVIATOR PLUS PTA BALLOON CATHETER WAS USED AS A REPLACEMENT AND WAS INFLATED TO 10ATM WITHOUT ISSUE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING AN ENDOVASCULAR THERAPY (EVT) PROCEDURE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) LESION. A CONTRALATERAL APPROACH WAS MADE WITH A 6F NON-CORDIS SHEATH. AN UNKNOWN GUIDEWIRE WAS USED TO CROSS THE LESION PRIOR TO USE OF THE AVIATOR PLUS PTA BALLOON CATHETER. A NON-CORDIS BALLOON CATHETER WAS ALSO USED DURING THIS PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21816179 ↗
• MalfunctionDec 16, 2021Burst Container or Vessel; Burst Container or Vessel

  A .014 5.0X40 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT NOMINAL PRESSURE DURING USE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017960 ↗
• MalfunctionApr 14, 2021Leak/Splash; Leak/Splash

  AS REPORTED, THE DOCTOR PROCEEDED TO INFLATE THE BALLOON BUT THE .014 5.0 X 40 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WOULD NOT HOLD PRESSURE AND LEAKAGE WAS NOTED FROM THE BALLOON. THEREFORE, THE BALLOON WAS REMOVED. THERE WAS NO HARM AND NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN PATIENT. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN STERILE FIELD. THE BALLOON WAS PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE EVENT OCCURRED INSIDE THE PATIENT DURING A PROCEDURE IN THE CAROTID ARTERY. THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. NO KINKS OR OTHER DAMAGES WERE NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. THE CONTRAST TO SALINE RATIO WAS 50/50. AN INDEFLATOR WAS USED AS THE INFLATION DEVICE AND THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE PLUNGER DEPRESSED INTO THE SYRINGE/INDEFLATOR WHEN TRYING TO INFLATE. ADDITIONAL PATIENT AND PROCEDURAL DETAILS WERE REQUESTED BUT WERE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11663935 ↗
• MalfunctionMay 11, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A RUPTURE WAS FOUND ON THE BALLOON OF A 5.0MM X 40MM 142CM .014¿ AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DURING PREP. THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER AVIATOR PLUS PTA BALLOON. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). THERE WERE NO DAMAGES NOTED TO THE PACKAGING OF THE DEVICE PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE WAS PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE). THE TARGET LESION WAS THE RENAL ARTERY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10043416 ↗
• MalfunctionJul 15, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THIS WAS AN ENDOVASCULAR TREATMENT (EVT) CASE, AN AVIATOR PLUS 014 5.0X40 142CM WAS USED FOR A PRE-DILATATION, HOWEVER IT RUPTURED AT ITS NOMINAL PRESSURE. THERE WERE NO REPORTED PATIENT INJURIES. THEREFORE IT WAS REPLACED WITH A NEW BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8790688 ↗