AVIATOR 4244040WRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032005767), received between Sep 14, 2020 and Aug 28, 2023 — classified as 2 malfunctions.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2023Leak/Splash; Leak/Splash

  AS REPORTED, THE 4.0X40 .014 AVIATOR PLUS WAS TAKEN OUT OF THE POUCH FOR PRE-PTA. THE THREE-WAY STOPCOCK WAS ATTACHED, AND DEFLATION WAS PERFORMED AS USUAL, BUT THE DEFLATION KEPT GOING INCESSANTLY, SO A RUPTURE OF THE BALLOON OR A LEAK IN THE SHAFT OR HUB WAS EXPECTED, SO THE PRODUCT WAS NOT USED. THE LEAK WAS NOTICED DURING PREP OF THE BALLOON BEFORE USE. WHEN THE AVIATOR PLUS WAS INFLATED OUTSIDE THE PATIENT'S BODY, THE BALLOON EXPANDED, BUT A LOT OF AIR WAS MIXED IN. IT IS UNKNOWN WHERE THE AIR IS COMING FROM, BUT IT SEEMS THAT THE PRODUCT IS DEFECTIVE. THE SAME SIZE BALLOON (NON-CORDIS) WAS USED FOR DILATION, A 10MM STENT WAS IMPLANTED, AND AN AVIATOR 5MM X 3CM WAS USED FOR POST-PTA, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE LESION WAS THE STENOSIS AT THE CAROTID ARTERY. AN APPROACH WAS MADE FROM THE RIGHT INGUINAL REGION TO THE COMMON CAROTID ARTERY WITH A 8F NON-CORDIS GUIDING CATHETER FOR BACK-UP. A SPIDER PROTECTION GUIDEWIRE WAS INSERTED AND ADVANCED TO THE DISTAL INTERNAL CAROTID ARTERY. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630710 ↗
• MalfunctionSep 14, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE .014 4.0 X 40 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529029 ↗