AVIATOR 4246040WRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705032005927), received between Mar 27, 2020 and Jun 14, 2024 — classified as 2 injuries, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A .014 6.0X40 AVIATOR WAS USED FOR CAROTID ARTERY STENTING (CAS) CASE, BUT THE CALCIFICATION OF THE LESION WAS SO SEVERE THAT THE BALLOON BURST DURING INFLATION. THE DEVICE COULD NOT BE USED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537706 ↗
• InjuryNov 9, 2021Difficult to Remove; Difficult to Remove

  DURING POST-DILATATION OF AN 8MM X 4MM PRECISE STENT WITH A 5MM X 4CM AVIATOR PLUS BALLOON CATHETER, THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY WITHDRAW THE BALLOON CATHETER. THE REMOVAL CAUSED MOVEMENT OF THE ANGIOGUARD EMBOLIC PROTECTION DEVICE IN PLACE, RESULTING IN SEVERE SPASM OF THE LEFT INTERNAL CAROTID ARTERY. IT ALSO RESULTED IN TRANSIENT THROMBOTIC OCCLUSION OF THE INTERNAL CAROTID ARTERY AND THE PATIENT SUFFERED A STROKE. THERE WAS ALSO DIFFICULTY CLOSING AND REMOVING THE ANGIOGUARD DEVICE WHICH WAS REMOVED PARTIALLY COLLAPSED. THE THROMBUS WAS ASPIRATED. THE PATIENT SUFFERED A STROKE COMPLAINING OF RIGHT ARM AND LEG WEAKNESS, EXPRESSIVE DYSPHASIA AND CONFUSION. AN URGENT CT SCAN WAS PERFORMED AND THIS DID NOT REVEAL ANY ACUTE STROKE OR HAEMORRHAGE. THE PATIENT WAS TREATED CONSERVATIVELY BY THE RADIOLOGY NURSING STAFF AND MADE A SIGNIFICANT RECOVERY IN THE RADAR ANALYSIS AND DEVELOPMENT UNIT (RADU). THE PATIENT WAS CONVERTED FROM ASPIRIN TO CLOPIDOGREL. THE PATIENTS ARM AND LEG WEAKNESS RESOLVED, HE WAS LESS CONFUSED BUT STILL HAD SOME RESIDUAL EXPRESSIVE DYSPHASIA. A LEFT CAROTID STENTING PROCEDURE WAS BEING PERFORMED. UNDER ULTRASOUND GUIDANCE A LEFT COMMON FEMORAL ARTER

  Patient problems: Stroke/CVA; Vasoconstriction

  MAUDE report 12778478 ↗
• MalfunctionOct 14, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A .014¿ 6MM X 40MM X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER, HOWEVER, IT RUPTURED AT 6 ATMOSPHERES (ATM). THEREFORE, THE DEVICE WAS REPLACED WITH THE SAME SIZE SABER RX PTA BALLOON AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED DUE TO COVID-19.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631846 ↗
• MalfunctionNov 10, 2020Deflation Problem; Deflation Problem

  AS REPORTED, A .014¿ 6.0 X 40 X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FILLED WITH BLOOD AND WOULD NOT FULLY DEFLATE. THE BALLOON INFLATED NORMALLY BUT IT FILLED WITH BLOOD. THE BALLOON DEFLATED SOME BUT NOT FULLY. THEREFORE, THE ENTIRE SYSTEM WAS REMOVED, INCLUDING AN UNKNOWN FILTER BASKET AND UNKNOWN GUIDE TOGETHER, AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER UNKNOWN DEVICE. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT REMAINS IN GOOD CONDITION. THE INTENDED PROCEDURE WAS A CAROTID ARTERY INTERVENTION. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, REMOVING THE PROTECTIVE BALLOON COVER, OR REMOVING 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 DEVICE PREPPED NORMALLY. AN UNKNOWN INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL OR CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10815791 ↗
• InjuryMar 27, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE AVIATOR PLUS .014¿ 6.0MMX40MM 142CM WAS INSERTED AND BLOWN UP TO NOMINAL PRESSURE. HOWEVER, THE BALLOON BROKE AT NOMINAL PRESSURE BECAUSE OF THE LARGE CALCIFIED PLAQUE IN VESSEL. THERE WAS AN INJURY TO THE PATIENT. THEY TOOK PICTURE AND SAW LARGE EXTRAVASATION. SHEATH, ANGIOGUARD, AND STENT WERE PLACED WITH NO ISSUES. THE SHEATH WAS EXCHANGED AND NON-CORDIS COVERED STENT WAS PLACED, FOLLOWED BY 6X40 NON-CORDIS BALLOON. NO EXTRAVASATION SEEN ON POST PICTURE IN 2 ANGLES. ACCORDING TO THE SURGEON, THERE WAS PLAQUE RUPTURE WITH THE DEPLOYMENT OF STENTING AND BALLOON ANGIOPLASTY. THE HEAVILY CALCIFIED PLAQUE MAY HAVE CAUSED THE BALLOON TO RUPTURE. THE PATIENT REQUIRED A SECONDARY PROCEDURE, STENTING WITH COVERED STENT X 2. AS PER THE SALES REP, THE PATIENT EXPERIENCED SYMPTOMS OF A STROKE, THE PATIENT WAS NON-VERBAL/NON-MOTOR RESPONSES AND WAS SENT DIRECTLY TO CATSCAN. THE PATIENT BEGAN RECOVERING MOTOR FUNCTIONS DURING THE SCAN. THE LESION HAD MODERATE TO SEVERE PLAQUE CALCIFICATION. THERE WAS NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS GREATER THAN 50%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION AND WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR U

  Patient problems: Extravasation; Stroke/CVA

  MAUDE report 9889468 ↗