AVIATOR 4245015WRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032005811), received between Sep 28, 2017 and May 19, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2021Material Rupture; Material Rupture

  DURING A RENAL ARTERY STENTING CASE, A 014¿ 5.0 X 15 X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR PRE-PTA, HOWEVER, IT RUPTURED AT 6 ATMOSPHERES (ATM). IT WAS REMOVED FROM THE PATIENT WITHOUT ANY PROBLEMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING A NEW BALLOON CATHETER. THERE WAS NO PATIENT INJURY. THERE WAS NO VESSEL TORTUOSITY. THE ACCESS SITE WAS THE FEMORAL ARTERY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR ANY DIFFICULTY REMOVING THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE. THE CONTRAST TO SALINE RATIO WAS 1:2. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11851804 ↗
• MalfunctionJul 23, 2019Crack; Crack

  AS REPORTED, THE 5.0X15 AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) WAS USED FOR THE RENAL ARTERY WITH A STENT GRAFT BACKUP, HOWEVER THE SHAFT OF THE AVIATOR PLUS CRACKED WHILE IT WAS PUSHED TO SECURE THE RENAL ARTERY. NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS REPLACED WITH A NEW, DIFFERENT LENGTH AVIATOR PLUS AND THE PROCEDURE WAS CONTINUED. THE INTENDED TREATMENT SITE AND TARGET LESION WAS THE RENAL ARTERY. THE LESION HAD A LITTLE CALCIFICATION, MODERATE ANGULATION, AND MODERATE TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS SEVENTY-FIVE PERCENT. THE DEVICE WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND IT PREPPED NORMALLY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE TO THE TARGET LESION. EXCESSIVE TORQUING WAS NOT REQUIRED. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THERE WERE NO STENTS PRESENT WITHIN THE TREATMENT SITE OR THE TRACKING PATH. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DEVICE. THE PRODUCT WAS R

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8816115 ↗
• MalfunctionSep 28, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A AVIATOR PLUS BALLOON CATHETER WAS DELIVERED TO THE LESION AND INFLATED. HOWEVER IT RUPTURED AT ITS NOMINAL PRESSURE. THEREFORE IT WAS REPLACED WITH A SAME SIZE NEW UNKNOWN BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOSITY AND CALCIFICATION WAS UNKNOWN. THE RATE OF STENOSIS WAS UNKNOWN. THE DEVICE PREP NORMALLY. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, 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 PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6900813 ↗