AVIATOR 4244520WRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032005781), received between Oct 31, 2019 and Mar 2, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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.

• MalfunctionMar 2, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A .014 5.0X30 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED BUT BACK-FLOW WAS OBSERVED IN THE INDEFLATOR BEFORE THE COMPLAINT DEVICE REACHES THE LESION. THE COMPLAINT DEVICE WAS CHECKED OUTSIDE THE PATIENT AND BALLOON RUPTURE WAS CONFIRMED. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER AVIATOR PLUS AND THE LESION WAS INFLATED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNAVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16473385 ↗
• MalfunctionNov 1, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A 014¿ 4.5MM X 20MM X 142MM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED; HOWEVER, IT RUPTURED AFTER BEING INFLATED SEVERAL TIMES. THE PRESSURE WHEN IT RUPTURED WAS UNCLEAR. IT WAS THEN REPLACED WITH ANOTHER 5MM AVIATOR PLUS PTA BALLOON CATHETER (UNKNOWN), AND THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS FOR A BALLOON PULMONARY ANGIOPLASTY (BPA) CASE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION COULD NOT BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12734266 ↗
• MalfunctionOct 31, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THIS WAS A CAROTID ARTERY STENTING (CAS) CASE, AND AN AVIATOR PLUS .014 4.5X20 142CM WAS USED FOR POST DILATION, HOWEVER IT RUPTURED AT SIX ATMOSPHERES. THERE WERE NO REPORTED PATIENT INJURIES. THE AVIATOR WAS REPLACED WITH A NEW KANEKA BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE DEVICE WAS DISCARDED DUE TO INFECTION DISEASE. THE DEVICE WAS STORED ON A SHELF IN THE CATH LAB. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE SALINE TO CONTRAST RATIO WAS 1:2. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE CATHETER WAS REMOVED EASILY AND INTACT. THE TARGET LESION WAS THE INTERNAL CAROTID. THE LESION WAS LITTLE CALCIFIED WITH NO VESSEL TORTUOSITY. THE LESION HAD EIGHTY PERCENT STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261480 ↗