Fortrex™ A35HPV10040080 (UDI 00763000106348)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000106348), received between Jul 26, 2022 and Dec 14, 2025 — 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING NEGATIVE PREPARATION PRIOR TO INSERTION INTO THE PATIENT, A PIN HOLE LEAK WAS OBSERVED IN THE BALLOON OF THE FORTREX 10X040X80 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. THE TARGET LESION FOR TREATMENT WAS A CHRONIC TOTAL OCCLUSION (100% STENOSIS) OF THE PROXIMAL RIGHT SHORT SAPHENOUS VEIN, WITH MODERATE TORTUOSITY AND NO CALCIFICATION. THE BALLOON WAS INFLATEDUSING AN INFLATION DEVICE AT 4ATM. THE DEVICE WAS PREPPED PER INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED. THE PROCEDURE WAS COMPLETED BY REPLACING THE BALLOON WITH ANOTHER FROM THE SAME LOT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23799506 ↗
• MalfunctionMay 27, 2024Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER WITH A 7FR SHEATH AND A 0.035 GUIDEWIRE DURING PATIENT TREATMENT. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. HEP SALINE WAS USED FOR INFLATION FLUID. A BALLOON BURST DURING INFLATION AT 16ATMS WAS REPORTED. ISSUE OCCURRED ON FIRST INFLATION. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. THE BALLOON DID NOT DETACH DURING THE EVENT AND THE DEVICE SAFELY REMOVED FROM THE PATIENT. NO VESSEL INJURY WAS NOTED. ANOTHER BALLOON BRAND WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399939 ↗
• MalfunctionApr 19, 2024Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER DURING PATIENT TREATMENT. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. THE VESSEL WAS NOT PRE OR POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST INFLATION FLUID WAS USED. A BALLOON BURST WAS REPORTED. THE BALLOON DID NOT DETACH DURING EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143497 ↗
• MalfunctionFeb 1, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A FORTREX BALLOON TO TREAT A PLAQUE LESION IN THE MID CEPHALIC VENOUS ANASTOMOSIS. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS LITTLE. LESION STENOSIS WAS 70%. EMBOLIC PROTECTION USED WAS NOT USED. BALLOON INFLATED WITH A GENOSS DEVICE. DEVICE WAS PREPPED PER IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THERE WAS A LONGITUDINAL BALLOON BURST DURING INFLATION UNDER THE NOMINAL PRESSURE. ALL BALLOON FRAGMENTS RETRIEVED. PROCEDURE COMPLETED BY USING A NEW FORTREX BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627900 ↗
• MalfunctionOct 14, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A FORTREX BALLOON TO TREAT A PLAQUE LESION IN THE PROXIMAL AV FISTULA IN UPPER ARM. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS NONE. LESION STENOSIS WAS 70%. EMBOLIC PROTECTION WAS NOT USED. BALLOON WAS INFLATED WITH A GENOSS DEVICE. DEVICE WAS PREPPED PER IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THERE WAS A CIRCUMFERENTIAL/RADIAL BALLOON BURST DURING BALLOON INFLATION AT INFLATION UP TO RBP ((B)(4)). ALL FRAGMENTS OF THE BALLOON RETRIEVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936777 ↗
• MalfunctionMay 23, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A FORTREX BALLOON TO TREAT A FIBROUS SOFT TISSUE LESION IN THE MID COMMON ILIAC ARTE RY. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS LITTLE. LESION STENOSIS WAS 60%. EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. DEVICE WAS PREPPED PER IFU. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT  ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT BALLOON BURST AT 16 ATM. BURST WAS LONGITUDINAL. ALL FRAGMENTS WERE RETRIEVED. PROCEDURE COMPLETED BY USING ANOTHER SAME SIZE FORTREX BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982259 ↗
• MalfunctionNov 30, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE FORTREX BALLOON TO TREAT A LESION WITH CENTRAL VENOUS STENOSIS. IT WAS REPORTED THAT WHEN THE BALLOON WAS INSERTED INTO THE PATIENT DURING THE PROCEDURE, IT WAS FOUND THAT THE MID-END OF THE BALLOON RUPTURED. THE BALLOON RUPTURED BEFORE REACHING THE BURST PRESSURE. THE PROCEDURE WAS COMPLETED BY REPLACING THE BALLOON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884805 ↗
• MalfunctionAug 2, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE AN FORTREX PTA BALLOON WITH A 7FR NON-MEDTRONIC (CORDIS) SHEATH AND A .035 NON-MEDTRONIC (AMPLATZ) GUIDEW IRE DURING TREATMENT OF A FIBROUS LESION IN THE PATIENT¿S RIGHT PROXIMAL ARTERIOVENOUS FISTULA (AVF). MODERATE VESSEL CALCIFICATION AND NO VESSEL TORTUOSITY ARE REPORTED. LESION EXHIBITED 95% STENOSIS. A MEDTRONIC (AC3200) INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED A CIRCUMFERENTIAL/RADIALBALLOON BURST OCCURRED AT 15ATM DURING BALLOON INFLATION. THE PHYSICIAN WAS EVENTUALLY ABLE TO SAFELY REMOVE THE BURST BALLOON THROUGH THE SHEATH. ALL PARTS OF THE BALLOON WERE REMOVED. A NEW FORTREX BALLOON WAS USED TO COMPLETE THE ANGIOPLASTY. THE PROCEDURE WAS ENDED. NO VESSEL INJURY. NO INTERVENTION USED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147732 ↗
• MalfunctionJul 26, 2022Use of Device Problem; Use of Device Problem

  PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON DURING A CALCIFIED AVF PROCEDURE. INFLATION DEVICE WAS USED FOR BALLOON INFLATION. SALINE AND DYE WAS USED AS INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THERE WAS NO VASCULAR INJURIES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. BALLOON WAS USED PAST ITS DUE DATE. PHYSICIAN KNEW THAT THE PRODUCT HAD EXPIRED AND USED IT. PHYSICIAN USED ANOTHER BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103613 ↗