AVIATOR 4246030WRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032005910), received between Nov 20, 2023 and Nov 20, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, DURING INFLATION OF A 6MM X 30MM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER TO 13 ATMOSPHERES (ATM), THE DISTAL TIP OF THE BALLOON RUPTURED AND EXTRAVASATED CONTRAST MEDIUM. A 4 X 30 NON-CORDIS BALLOON CATHETER WAS USED AS A REPLACEMENT AND DILATED TO 13 ATM. THE PROCEDURE WAS UNEVENTFUL, AND THE EXTRAVASATION HAD IMPROVED ON ITS OWN WITHOUT TREATMENT. THIS WAS DURING A PROCEDURE TO STENT A 75% STENOSED LEFT INTERNAL CAROTID ARTERY LESION WHICH HAD MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE AVIATOR PLUS PTA BALLOON CATHETER WAS BEING USED TO POST-DILATE AN UNKNOWN STENT. THE DEVICE WAS STORED HANDLED AND PREPPED FOR THE INSTRUCTIONS FOR USE AND THERE WAS NO DIFFICULTY REMOVING ANY OF THE STERILE PACKAGING COMPONENTS. A 50/50 CONTRAST AND SALINE MIXTURE WAS USED TO PREP THE DEVICE. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. THE HOSPITAL REPORTED IT AS AN ADVERSE EVENT TO THE CHINA NMPA DIRECTLY.

  Patient problems: Extravasation

  MAUDE report 18169044 ↗