AVIATOR 4244030WRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705032005750), received between Feb 23, 2018 and Oct 15, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, WHILE FLUSHING THE GUIDEWIRE LUMEN ON A 4MM X 30MM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER DURING PREPARATION, IT WAS DISCOVERED THAT THE BALLOON WAS ALREADY CRACKED, AND A LEAKAGE OF FLUID WAS COMING FROM THE BALLOON MATERIAL. A NEW 4MM X 30MM CORDIS BALLOON WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PACKAGING AND NO DIFFICULTY REMOVING STERILE PACKAGING COMPONENTS. THE DEVICE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23277986 ↗
• MalfunctionMar 8, 2021Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, A .014¿ 4.0 X 30 X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS USED FOR POST-DILATION. HOWEVER, IT RUPTURED DURING ITS INITIAL INFLATION. THERE WAS NO REPORTED PATIENT INJURY. THIS WAS A CAROTID ARTERY STENTING (CAS) CASE. THE DEVICE WAS BROUGHT TO THE CATH LAB ON THE DAY OF THE PROCEDURE. 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. THE TARGET LESION WAS THE CAROTID ARTERY, WITH MODERATE CALCIFICATION. THE VESSEL TORTUOSITY WAS NOT SEVERE. THERE WAS NINETY NINE PERCENT STENOSIS. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE SAME INDEFLATOR WAS USED SUCCESSFULLY WITH OTHER DEVICES. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE BALLOON RUPTURE DURING THE INITIAL INFLATION. THE BALLOON CATHETER WAS REMOVED EASILY AND INTACT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436774 ↗
• MalfunctionMay 6, 2019Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE AVIATOR PLUS (.014 4.0X30 142CM) BALLOON RUPTURE AT 9 ATMOSPHERES (ATM). THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8581968 ↗
• MalfunctionFeb 23, 2018Leak/Splash; Leak/Splash

  AS REPORTED, WHEN THE AVIATOR PLUS .014 4.0X30 142CM BALLOON CATHETER WAS USED IN THE PATIENT'S BODY, THE BALLOON WAS LEAKED, SO RESULT IN THE BALLOON CAN NOT BE EXPANDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7293618 ↗