AVIATOR 4245030WRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20705032005835), received between Oct 27, 2019 and Mar 25, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2024Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE BALLOON OF A 5MM X 30MM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED WHEN INFLATED TO 12 ATMOSPHERES (ATM) AFTER BEING DELIVERED TO THE LESION. AN UNKNOWN BALLOON CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. AN UNKNOWN PROTECTIVE ¿UMBRELLA¿ WAS PLACED PRIOR TO THE USE OF THE AVIATOR PLUS PTA BALLOON CATHETER. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968904 ↗
• MalfunctionFeb 2, 2023Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED, THE AVIATOR PLUS DEVICE WAS USED AS PRE-DILATION BUT RUPTURED WITHIN ITS NOMINAL PRESSURE. THE COMPLAINT DEVICE WAS REMOVED, AND THE PROCEDURE COMPLETED. THERE WAS REPORTED INJURY TO THE PATIENT. THE LESION WAS THE SUBCLAVIAN REGION. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286007 ↗
• MalfunctionOct 21, 2021Burst Container or Vessel; Burst Container or Vessel

  WHEN A .014¿ 5MM X 30MM X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER REACHED THE APPROPRIATE POSITION AND THE UNKNOWN GUIDEWIRE WAS REPLACED, THE BALLOON WAS PUNCTURED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE INTERNAL CAROTID ARTERY AND WAS DILATED WITH THE AVIATOR PLUS PTA BALLOON. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674353 ↗
• MalfunctionOct 4, 2021Leak/Splash; Leak/Splash

  AS REPORTED, A 014¿ 5.0 X 30 X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER WAS PREPARED ACCORDING TO THE STANDARD PROCESS; HOWEVER, WHEN IT WAS SENT THROUGH THE VESSEL TO REACH THE LESION, IT WAS PRESSURIZED BY AN NON-CORDIS PRESSURE PUMP FILLED WITH 1:1 SALINE/CONTRAST AND THE BALLOON DILATED POORLY. THE CONTRAST ALSO LEAKED AND THE BALLOON BROKE. IT WAS THEN REPLACED WITH A NEW NON-CORDIS BALLOON TO COMPLETE OPERATION. THERE WAS NO REPORTED PATIENT INJURY. THE LEAK WAS NOTICED WHILE THE DEVICE WAS IN THE PATIENT AND THEN VERIFIED OUTSIDE THE PATIENT. THE PRODUCT WAS PROPERLY STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY NOTED WHILE REMOVING THE DEVICE FROM THE HOOP, REMOVING THE STYLET AND/OR ANY OF THE STERILE PACKAGING COMPONENTS, AND REMOVING THE PROTECTIVE BALLOON COVER. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PREPPER NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE BALLOON CATHETER WAS BEING USED TO DILATE THE RIGHT VERTEBRAL ARTERY. THE VESSEL WAS NOT TORTUOUS; HOWEVER, THE LESION DID HAVE A LITTLE CALCIFICATION. THE LESION HAD A 75% ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572721 ↗
• MalfunctionMar 22, 2021Leak/Splash; Leak/Splash

  DURING DEVICE PREPARATION, STERILE HEPARIN SALINE LEAKED FROM THE BALLOON OF A .014¿ 5.0 X 30 X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER. SO, IT COULD NOT BE USED ON PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON WAS REPLACED WITH ANOTHER AVIATOR BALLOON AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE TARGET LESION WAS IS THE INTERNAL CAROTID ARTERY WHICH WAS MILDLY CALCIFIED AND TORTUOUS. THE DEVICE WAS STORED AND PREPPED AS PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DAMAGE NOTICED ON THE DEVICE PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WERE NO DIFFICULTIES REMOVING THE PRODUCT FROM THE HOOP, THE PROTECTIVE BALLOON COVER, THE STYLET OR ANY OF THE STERILE PACKAGING COMPONENTS. A COMPETITOR'S CONTRAST MEDIA. THE SAME INDEFLATOR USED SUCCESSFULLY WITH OTHER DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO DAMAGE NOTED ON THE BALLOON. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11542953 ↗
• MalfunctionDec 16, 2020Material Rupture; Material Rupture

  A .014¿ 5.0 X 30 X 142CM AVIATOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER RUPTURED DURING AN INTERVENTIONAL PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION. THE PROCEDURE BEING PERFORMED WAS A VENOUS SINUS STENT PLACEMENT. ACCESS WAS VIA THE RIGHT GROIN. THE LESION WAS NOT CALCIFIED AND THERE WAS NO VESSEL TORTUOSITY. IT WAS ALSO NOT A CHRONIC TOTAL OCCLUSION (CTO) LESION. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE FORMING TUBE OR ANY OF THE PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY. A 3ML SYRINGE WAS USED WITH VISIPAQUE CONTRAST. THE SAME INDEFLATOR USED SUCCESSFULLY WITH OTHER DEVICES. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE AND NO RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND NO DIFFICULTY CROSSING THE LESION. THE CATHETER WAS NOT IN AN ACUTE BEND AND INFLATED NORMALLY. THE CATHETER DID NOT KINK WHILE BEING USED AND WAS EASILY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11021424 ↗
• MalfunctionOct 27, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING USE IN A CORONARY ARTERY STENTING CASE, AN AVIATOR PLUS WAS USED FOR A POST DILATION BUT IT RUPTURED AT EIGHT ATMOSPHERE (8 ATM). THERE WAS NO PATIENT INJURY. THE AVIATOR PLUS WAS REPLACED WITH ANOTHER BALLOON CATHETER (COMPETITIVE PRODUCT) AND THE PROCEDURE COMPLETED. THE PHYSICIAN COMMENTED THAT THIS ISSUE MIGHT HAVE OCCURRED BY THE STENT EDGE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9243441 ↗