AVIATOR 4247040WRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032005965), received between May 1, 2020 and May 1, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMay 1, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  DURING USE OF .014 7.0X40 142CM AVIATOR PLUS BALLOON CATHETER (BC) WAS DEFLATED AND ATTEMPTED TO BE REMOVED FROM THE SHEATH HOWEVER, IT COULD NOT BE REMOVED FROM THE SHEATH AND THE SHAFT GOT SEPARATED. THE PROCEDURE WAS COMPLETED BECAUSE THERE WAS NO PROBLEM. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS VASCULAR ACCESS INTERVENTION THERAPY (VAIVT) CASE. THE LESION WAS THE STENOSIS JUST ABOVE THE ANASTOMOSIS. ARTERIAL APPROACHED WAS MADE. THE SEPARATION OCCURRED AT THE OUTLET OF THE SHEATH, AND THE REST WAS INSIDE THE SHEATH AND COULD BE REMOVED. THE SHEATH WAS REINSERTED, AND FINAL IMAGING WAS PERFORMED TO CHECK FOR ANY RESIDUE. DURING THE PRODUCT EVALUATION, THE BALLOON WAS OBSERVED SEPARATED NEAR THE PROXIMAL SEAL AREA OF THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10017580 ↗