Fortrex™ A35HPV07040080 (UDI 00763000106102)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000106102), received between Sep 16, 2019 and Aug 6, 2024 — 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.

• MalfunctionAug 6, 2024Leak/Splash; Leak/Splash

  A PHYSICIAN ATTEMPTED TO USE A FORTREX HP BALLOON PRIOR TO PATIENT TREATMENT. 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) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITH AN ISSUE NOTED. 50/50 CONTRAST INFLATION FLUID WAS USED. IT WAS REPORTED LEAK WAS NOTED DURING PREPARATION. THIS ISSUE IS REPORTED FOR 3 BALLOONS. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919396 ↗
• MalfunctionJul 18, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A FORTREX BALLOON TO TREAT A LESION. DEGREE OF TORTUOSITY WAS NONE. DEGREE OF CALCIFICATION WAS NONE. EMBOLIC PROTECTION WAS NOT USED. BALLOON INFLATED WITH A SYRINGE. DEVICE PREPPED PER IFU. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THERE WAS A CIRCUMFERENTIAL/RADIAL BURST DURING THE SECOND INFLATION AT 18 ATMS, BELOW RATED BURST PRESSURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339981 ↗
• MalfunctionMay 19, 2023Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE A FORTREX BALLOON FOR THE TREATMENT OF A CHRONICALLY TOTALLY OCCLUDED CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS MODERATELY CALCIFIED. EMBOLIC PROTECTION WAS NOT USED. AN UNKNOWN INFLATION DEVICE WAS USED. THE BALLOON WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE BALLOON BURST DURING BALLOON INFLATION AT 18ATM. THE BALLOON WAS REMOVED INTACT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16961067 ↗
• MalfunctionSep 16, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A FORTREX PTA BALLOON TO TREAT A FISTULA. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TOTHE TARGET LESION. THE DEVICE WAS INFLATED BUT, ON FIRST INFLATION AND AT 0ATM, A LEAK WAS OBSERVED AT THE LUER/HUB. ANOTHER PTA WAS USE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9069021 ↗