AVIATOR 4244020WRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20705032005743), received between Apr 10, 2018 and Jun 27, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2022Leak/Splash; Leak/Splash

  AS REPORTED, THE BALLOON OF A 4.0MM X 20MM 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS PUNCTURED AND COULD NOT BE INFLATED OR MAINTAIN PRESSURE DURING THE ATTEMPTED INFLATION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A CAROTID ARTERY STENTING PROCEDURE. THE DEVICE WAS STORED AND PREPARE PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO KINKS OR DAMAGES OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS N DIFFICULTY CROSSING THE LESION WITH THE AVIATOR PLUS PTA BALLOON CATHETER. THE DEVICE WAS NEVER PUT INTO AN ACUTE BEND AND DID NOT KINK DURING ITS USE. AFTER THE BALLOON PUNCTURE WAS OBSERVED, THE BALLOON CATHETER WAS ABLE TO BE REMOVED EASILY AND REMAINED IN ONE PIECE DURING ITS REMOVAL. INFORMATION REGARDING THE PATIENT, TARGET LESION CHARACTERISTICS, AND WHETHER THE DEVICE MAINTAINED NEGATIVE PRESSURE DURING PREPARATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828400 ↗
• MalfunctionJun 7, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF AN AVIATOR PLUS .014 4X20 142CM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED AT THE STENOSIS OF THE INTERNAL CAROTID ARTERY WHEN THE PRESSURE REACHED SEVEN ATMOSPHERES (ATM). THE PROCEDURE WAS COMPLETED BY USING AN UNKNOWN 4X30 AND 6X 30 CORDIS BALLOON CATHETERS. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS SEVERELY CALCIFIED WITH LITTLE TORTUOSITY. THE LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) WITH A NINETY PERCENT STENOSIS. THERE WAS NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE BALLOON FROM THE HOOP. THERE WAS NO DIFFICULTY 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 DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE PREPPED NORMALLY. THE CONTRAST TO SALINE RATIO WAS 1:1. A NON-CORDIS IND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14619832 ↗
• MalfunctionSep 7, 2021Leak/Splash; Leak/Splash

  AS REPORTED, DURING DEVICE PREPARATION AVIATOR PLUS 4.0X20 142CM, A STERILE HEPARIN SALINE LEAKED FROM THE BALLOON, SO, IT COULD NOT BE USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE. THERE WAS NO DAMAGE TO THE DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE HOOP AND/OR REMOVING THE PROTECTIVE BALLOON COVER. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE INTENDED TARGET/LESION WAS THE CAROTID ARTERY. THE PROCEDURE WAS COMPLETED AFTER THE USE OF A NON-CORDIS BALLOON WITH THE SAME INFLATION DEVICE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434025 ↗
• MalfunctionApr 28, 2021Deflation Problem; Deflation Problem

  AS REPORTED, THE BALLOON OF THE 0.014¿ 4.0MM X 20MM X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER (BC) CAN'T BE COMPLETELY DEFLATED DURING THE DEFLATING PROCESS AND CAN'T REACH THE RECOVERY STANDARD SIZE. IT WAS ALSO NOTED THAT THE DEVICE WAS USED BEYOND THE EXPIRATION DATE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737727 ↗
• MalfunctionApr 26, 2021Deflation Problem; Deflation Problem

  AS REPORTED, A 014¿ 4MM X 20MM X 142MM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER CANNOT BE COMPLETELY DEFLATED DURING THE DEFLATING PROCESS AND IT CANNOT REACH THE ¿RECOVERY STANDARD SIZE¿. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION IS THE CAROTID ARTERY THAT WAS SEVERELY CALCIFIED AND TORTUOUS WITH EIGHTY-FIVE PERCENT STENOSIS. THERE WERE NO DIFFICULTY NOTED IN THE BALLOON DURING PREP. 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. A COMPETITOR'S INFLATION DEVICE WERE USED. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH OTHER DEVICES. AFTER THE BALLOON WAS USED, THERE WAS DIFFICULTY DEFLATING THE BALLOON AS IT TOOK FIFTEEN SECONDS TO DEFLATE THE BALLOON. THE BALLOON PROPERLY RE-WRAP AFTER DEFLATION AND THERE WERE NO DAMAGES NOTED TO THE BALLOON AFTER IT DEFLATED AND WAS REMOVED FROM THE PATIENT. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11728256 ↗
• MalfunctionSep 26, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE, THE AVIATOR BALLOON CATHETER BURST OUT OF VESSEL. THERE WAS NO PATIENT INJURY. THE DEVICE IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126592 ↗
• MalfunctionJul 18, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING A PERCUTANEOUS TRANSLUMINAL RENAL ANGIOPLASTY, IT WAS REPORTED THAT THE AVIATOR PLUS BALLOON CATHETER WAS DELIVERED TO THE LESION; HOWEVER, IT RUPTURED AROUND ITS NOMINAL PRESSURE DURING INITIAL INFLATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7700560 ↗
• MalfunctionApr 10, 2018Burst Container or Vessel; Burst Container or Vessel

  DURING USE, IT WAS REPORTED THAT THE AVIATOR BALLOON CATHETER RUPTURED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7411929 ↗