Fortrex A35HPV12040080Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00821684057872), received between Sep 14, 2017 and Dec 6, 2018 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2018Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN USED A FORTREX BALLOON TO TREAT A SEVERELY CALCIFIED LESION WITH CTO (CHRONIC TOTAL OCCLUSION 100%) IN A DISTAL ARTERIOVENOUS FISTULA. LESION LENGTH AND DIAMETER WERE 50MM AND 12 MM, RESPECTIVELY. IFU WAS FOLLOWED AND DEVICE WAS PREPPED WITHOUT ISSUES. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND SEVERE RESISTANCE WAS FELT DURING WITHDRAWAL AND EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE BALLOON BURST OCCURRED BELOW RATED BURST PRESSURE (RBP). PRESSURE. THE PHYSICIAN TRIED TO WITHDRAW BUT FELT THAT SOMETHING GOT STUCK AND THEN FORCED THE BALLOON TO PULL OUT WITH LITTLE BIT OF POWER. AFTERWARDS, THE BALLOON SPLIT BY THREE PIECES. THE PROCEDURE WAS COMPLETED USING ANOTHER HP BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8137467 ↗
• MalfunctionOct 4, 2018Burst Container or Vessel; Burst Container or Vessel

  IT IS REPORTED A BALLOON BURST OCCURRED. NO PATIENT INJURY WAS REPORTED. A DIFFERENT BALLOON WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7933383 ↗
• InjuryJun 12, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN USED A FORTREX BALLOON WITH A NON-MEDTRONIC 7 FR SHEATH AND .035 GUIDEWIRE FOR TREATMENT OF A 25MM AV FISTULA LESION. EMBOLIC PROTECTION WAS NOT USED. THE IFU WAS FOLLOWED. THE DEVICE WAS PREPPED WITHOUT ISSUE. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT IS REPORTED THAT DURING INFLATION TO 10 ATMOSPHERES, THE BALLOON RUPTURED IN THE PATIENT¿S VESSEL. AN ENSNARE DEVICE WAS USED TO TRY AND REMOVE THE DEVICE BUT THIS WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO A HOSPITAL FOR SUPRAVENTRICULAR TACHYCARDIA (SVT) AND A CONSULT TO REMOVE THE RUPTURED BALLOON. THE BALLOON FRAGMENT WAS NOT REMOVED FROM THE PATIENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND IS DOING FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7591926 ↗
• InjuryDec 15, 2017Burst Container or Vessel; Burst Container or Vessel

  A FORTREX PTA BALLOON CATHETER WAS USED IN A PROCEDURE. IT WAS REPORTED THAT THE BALLOON WAS INFLATED TO THE RATED BURST PRESSURE AND IMMEDIATELY RUPTURED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7123592 ↗
• InjuryDec 15, 2017Burst Container or Vessel; Burst Container or Vessel

  A FORTREX PTA BALLOON CATHETER WAS USED IN A PROCEDURE. IT WAS REPORTED THAT THE BALLOON WAS INFLATED TO THE RATED BURST PRESSURE AND IMMEDIATELY RUPTURED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7123566 ↗
• InjurySep 14, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO TREAT A 40MM CALCIFIED LESION LOCATED IN THE LEFT PROXIMAL COMMON ILIAC ARTERY WITH A FORTREX PTA BALLOON CATHETER. A 7F NON-MEDTRONIC SHEATH AND A 0.35 GUIDEWIRE WERE USED FOR THE PROCEDURE. THE LESION EXHIBITED A SEVERE DEGREE OF TORTUOSITY AND A SEVERE DEGREE OF CALCIFICATION WITH AN UNKNOWN % LESION STENOSIS. THE DIAMETER OF THE ARTERY IS 12MM. EMBOLIC PROTECTION WAS NOT USED. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE USING 50/50 FLUID. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT BUT NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE CATHETER AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THE BALLOON CATHETER DETACHED/CRACKED/FRACTURED AND THE BALLOON STRIPPED OFF DURING REMOVAL FROM A PATIENT. THE BREAK/FRACTURE OCCURRED AT THE BALLOON CATHETER AND THE DETACHED PORTION OF THE DEVICE REMAINED IN THE PATIENT. THE PHYSICIAN USED BRONCHOSCOPY FORCEPS DURING THE PROCEDURE TO REMOVE WHAT HE BELIEVED TO BE ALL THE REMNANTS LEFT IN THE BODY. SEVERAL HOURS POST PROCEDURE, AN ULTRASOUND DETERMINED A FLOW DEFECT. THE PATIENT EXPERIENCED VESSEL OCCLUSION DUE TO THE DEVICE COMP

  Patient problems: Device Embedded In Tissue or Plaque; Occlusion; Patient Problem/Medical Problem

  MAUDE report 6867135 ↗