AVIATOR 4246015WRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705032005897), received between Nov 16, 2020 and Feb 18, 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.

• MalfunctionFeb 18, 2021Material Rupture; Material Rupture

  DURING USE A .014 6.0 X 15 X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT 10 ATMOSPHERES (ATM) DURING ITS INITIAL INFLATION. THEREFORE, IT WAS REPLACED WITH A SAME SIZE NEW NON-CORDIS BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE LEFT RENAL ARTERY WITH STRONG CALCIFICATION AND SHORT STENOSIS. A .070 RENAL CURVE I VISTA BRITE TIP GUIDING CATHETER AND A 6F 25CM UNKNOWN SHEATH WERE USED DURING A RIGHT FEMORAL APPROACH. A NON-CORDIS GUIDEWIRE CROSSED THE LESION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11342550 ↗
• MalfunctionDec 22, 2020Difficult to Remove; Difficult to Remove

  AS REPORTED, A .014¿ 6.0 X 15 X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR PRE-PTA; BUT IT WAS NOT ABLE TO CROSS THE LESION. AFTER EXPANDING THE PART WHERE THE BALLOON CATHETER ENTERED THE STENOSIS A LITTLE AND DEFLATING; THE PHYSICIAN TRIED TO PASS THE DEVICE THROUGH THE STENOSIS AGAIN, BUT THE SAME ISSUE CONTINUED. THE PHYSICIAN THEN REMOVED THE BALLOON CATHETER, HOWEVER, IT GOT CAUGHT IN THE NON-CORDIS GUIDING SHEATH AND BECAME DIFFICULT TO BE REMOVED. FORTUNATELY, THE AVIATOR PLUS PTA BALLOON COULD BE REMOVED AND THE PROCEDURE RESUMED. THE DEVICE WAS REPLACED WITH AN UNKNOWN 4MM X 2CM BALLOON CATHETER, AND PTA WAS PERFORMED. AN UNKNOWN 6MM X 18MM STENT WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS AT THE ORIGIN PART OF THE RIGHT RENAL ARTERY. THE LESION WAS MODERATELY TORTUOUS WITH MODERATE CALCIFICATION. THE LESION HAD 90% STENOSIS AND WAS NOT A CTO. THE DEVICE WAS OPENED IN A STERILE FIELD. 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 KINK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055542 ↗
• MalfunctionNov 16, 2020Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A .014" 6MM X 15MM X 142MM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED AS A PRE-DILATION; BUT IT WAS NOT ABLE TO BE INFLATED WHEN PRESSURE EXCEEDED ITS NOMINAL PRESSURE. THE DOCTOR CONFIRMED THAT THE BLOOD WAS PULLED OUT AND CONFIRMED THE RUPTURE. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY (PTRA) CASE. THE LESION WAS THE STENOSIS AT THE RIGHT RENAL ARTERY. AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY. THE DEVICE WAS STORED IN THE CATH LAB FOR SIX HOURS. THE DEVICE WAS STORED, HANDLED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED NORMALLY BY MAINTAINING NEGATIVE PRESSURE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP, OR REMOVING THE PROTECTIVE BALLOON COVER. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. THERE WERE NO KINKS, OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE BALLOON CATHETER WAS REMOVED EASILY AND INTACT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS DUE TO INFECTIOUS DISEASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10844554 ↗