AVIATOR 4245020WRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20705032005828), received between Oct 26, 2016 and Dec 20, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN AVIATOR PLUS .014 5.0X20 142CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER BURST AFTER IT WAS INFLATED SEVERAL TIMES WITHIN THE SPECIFIED PRESSURE. IT WAS REPLACED WITH A NEW UNKNOWN AVIATOR AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS A "BPA" CASE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13046319 ↗
• MalfunctionNov 15, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN AVIATOR PLUS .014 5.0X20 142CM RUPTURED DURING THE PROCEDURE. THERE WAS LEAKAGE NOTED FROM THE BALLOON DURING INFLATION. THE PROCEDURE WAS COMPLETED USING ANOTHER UNKNOWN DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED FOR AN INTERVENTIONAL PERIPHERAL PROCEDURE. THE UNKNOWN TARGET VESSEL HAD MILD CALCIFICATION AND MILD TORTUOSITY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, OR REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). 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 AND THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12809661 ↗
• MalfunctionOct 22, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  AS REPORTED, AFTER OPENING THE OUTER PACKAGE OF THE AVIATOR PLUS .014 5.0X20 142CM, IT WAS FOUND THAT THE INNER PACKAGE OF THE BALLOON PRODUCT WAS NOT WELL SEALED. THE PRODUCT WAS STORED IN THE HOSPITAL EQUIPMENT CABINET, AND THE BARCODE ON THE OUTER PACKAGING IS REMOVED AND PASTED ON THE PATIENT SURGICAL INFORMATION RECORD FILE WHEN USED. IN THIS CASE, THERE WAS NO TRACE OF THE BARCODE THAT HAD BEEN REMOVED BEFORE THE OUTER PACKAGING WAS OPENED. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON WAS REPLACED WITH ANOTHER BALLOON. THE INTENDED PROCEDURE WAS A BALLOON DILATION OF PULMONARY HYPERTENSION. THE DEVICE WAS STORED IN THE LAB IN A CONSTANT TEMPERATURE AND HUMIDITY EQUIPMENT CABINET. THE PRODUCT WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682972 ↗
• MalfunctionSep 15, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE .014 5.0X20 142CM AVIATOR PLUS BALLOON CATHETER WAS USED BUT IT RUPTURED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS REPLACED WITH A NEW UNKNOWN DEVICE AND THE PROCEDURE WAS COMPLETED. THE AVIATOR WAS STORED ON THE SHELF. THIS WAS A RENAL ARTERY STENOSIS (RAS) CASE. THERE WERE NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, PROTECTIVE BALLOON COVER, STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO DAMAGES NOTED TO THE BALLOON. THERE WERE NO DIFFICULTY DURING PREPARATION. THE SAME INDEFLATOR DEVICE WAS USED SUCCESSFULLY WITH OTHER DEVICES. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISCARDED BY MISTAKE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12476395 ↗
• MalfunctionAug 17, 2020Leak/Splash; Leak/Splash

  A .014¿ 5.0MM X 20MM X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS INFLATED FAR FROM NOMINAL PRESSURE BUT THERE WAS HARDLY ANY OPENING VISIBLE. THE PROCEDURE WAS ABORTED, AND THE DEVICE WAS WITHDRAWN UNDER ASPIRATION AS USUAL. HOWEVER, THERE WAS BLOOD VISIBLE IN THE BALLOON PROBABLY BECAUSE OF A LEAKAGE. THE USER CONNECTED AN UNKNOWN REPLACEMENT PRODUCT OF THE SAME TYPE WITHOUT PROBLEMS. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO INDICATION OF A MALFUNCTION UNTIL INFLATION OF THE DEVICE IN THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE BEING PERFORMED WAS A CAROTID PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). ACCESS WAS VIA THE FEMORAL ARTERY. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP OR ANY DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE OR ANY RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THE TARGET LESION WAS CALCIFIED. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE USER WAS UNABLE TO DEPRESS THE PLUNGER INTO THE SYRINGE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10413463 ↗
• MalfunctionJul 10, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THE AVIATOR PLUS BALLOON CATHETER RUPTURE AT TEN ATMOSPHERES (10 ATM). THERE WAS NO PATIENT INJURY. THE AVIATOR PLUS BC WAS REPLACED WITH A NEW BALLOON CATHETER (5MM SHIDEN HP, KANEKA) FOR INFLATION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE LESION WAS THE LEFT COMMON FEMORAL ARTERY. THE LESION HAD HEAVY STENOSIS AND SEEMED TO BE HEAVILY CALCIFIED. AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A COMPETITOR'S 6F GUIDING SHEATH AND A COMPETITOR'S 235CM GUIDEWIRE CROSSED THE LESION. A COMPETITOR'S BALLOON CATHETER WAS INFLATED AND AN AVIATOR PLUS WAS DELIVERED TO THE LESION FOR INFLATION, HOWEVER IT RUPTURED AT APPROXIMATE 10 ATM DURING ITS INITIAL INFLATION. THE DEVICE WAS DISCARDED IN THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8776972 ↗
• MalfunctionJan 15, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A .014 5.0X20 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS FLUSHED AND USED AS PER THE INSTRUCTIONS FOR USE (IFU). HOWEVER, IT RUPTURED AT THE CALCIFICATION OF THE BLOOD VESSEL. NO PATIENT INJURY WAS REPORTED. THERE WERE NO ANOMALIES OF THE PACKAGE/DEVICE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS DUE TO SUSPICIOUS INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8247662 ↗
• MalfunctionOct 27, 2017Burst Container or Vessel; Burst Container or Vessel

  DURING AN EVT CASE, IT WAS REPORTED THAT AN AVIATOR BALLOON CATHETER (BC) WAS DELIVERED TO THE LESION FOR INFLATION. HOWEVER IT RUPTURED AT SEVEN (7) ATMOSPHERE (ATM). IT WAS UNKNOWN HOW THE PROCEDURE COMPLETED HOWEVER, 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 6985311 ↗
• MalfunctionOct 26, 2016Burst Container or Vessel; Detachment Of Device Component; Burst Container or Vessel; Detachment Of Device Component

  DURING PRE-DILATION WITH AN AVIATOR PLUS (.014 5.0X20 142CM) TO THE COMMON ILIAC ARTERY, IT WAS REPORTED THAT THE BALLOON CATHETER WAS DELIVERED TO THE LESION BUT IT RUPTURED. THEREFORE IT WAS REPLACED WITH ANOTHER AVIATOR PLUS AND THE PROCEDURE FINISHED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. N IPSILATERAL RETROGRADE APPROACH WAS MADE. A SHEATH INTRODUCER (6F 11CM) WAS INSERTED TO THE PATIENT. ࠔHE LESION WAS MILDLY CALCIFIED AND MILDLY TORTUOUS. THE RATE OF STENOSIS WAS 85%. PER VISUAL ANALYSIS, THE PRODUCT'S OUTER?DY WAS FOUND SEPARATED AT 11.5 CM FROM THE AVIATOR DISTAL END AND THE INNER LUMEN WAS FOUND ELONGATED 7.2 CM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6057986 ↗