Fortrex™ A35HPV12080080Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000106430), received between Nov 28, 2018 and Nov 30, 2022 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A FORTREX BALLOON TO TREAT A LESION WITH CENTRAL VENOUS STENOSIS. IT WAS REPORTED THAT WHEN THE BALLOON ENTERED THE PATIENT DURING THE PROCEDURE, IT WAS FOUND THAT THE MIDDLE END OF THE BALLOON RUPTURED. THE BALLOON RUPTURED WHEN THE BURST PRESSURE WAS NOT REACHED. THE PROCEDURE WAS COMPLETED BY USING A NEW BALLOON. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884808 ↗
• MalfunctionSep 26, 2022Burst Container or Vessel; Burst Container or Vessel

  A FORTREX PTA BALLOON CATHETER WAS INTENDED TO BE USED. THE BALLOON WAS INFLATED USING INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING OR WHEN REMOVING THE DEVICE FROM THE HOOT/TRAY. IT WAS REPORTED THE BALLOON BURST AT AN UNKNOWN ATM. ALL BALLOON FRAGMENTS WERE RETRIEVED. THE PHYSICIAN REPORTED THE BALLOON WAS DAMAGED DURING USE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15483890 ↗
• MalfunctionJan 18, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE THE FORTREX PTA BALLOON DURING PROCEDURE TO TREAT THE DISTAL RIGHT VESSEL. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS REPORTED THAT THERE WAS A LONGITUDINAL BALLOON BURST AT 10 ATM DURING BALLOON INFLATION. BALLOON RUPTURED AND ALL WAS REMOVED. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. NO INTERVENTION REQUIRED FOR REMOVAL. NO VESSEL DAMAGE NOTED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED BY BALLOON RUPTURED AND ALL REMOVED. THE SAME ISSUE OCCURRED WITH BOTH BALLOONS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13278344 ↗
• MalfunctionJan 18, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE THE FORTREX PTA BALLOON DURING PROCEDURE TO TREAT THE DISTAL RIGHT VESSEL. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS REPORTED THAT THERE WAS A LONGITUDINAL BALLOON BURST AT 10 ATM DURING BALLOON INFLATION. BALLOON RUPTURED AND ALL WAS REMOVED. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. NO INTERVENTION REQUIRED FOR REMOVAL. NO VESSEL DAMAGE NOTED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED BY BALLOON RUPTURED AND ALL REMOVED. THE SAME ISSUE OCCURRED WITH BOTH BALLOONS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13278291 ↗
• MalfunctionOct 27, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE THE FORTREX PTA BALLOON CATHETER DURING RENAL ACCESS PROCEDURE. THERE WAS NO LEAK NOTED AND NO LUER ADAPTER ISSUE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE FIRST BALLOON WAS FILLED TO THE RATED BURST PRESSURE OF 12 IN NORMAL USE. WHEN THE STENOSIS WAS FOUND NOT TO BE EXPANDED AND CONTINUED TO EXPAND IT WAS FILLED TO THE BURST PRESSURE OF 6 AND THE BALLOON RUPTURED LONGITUDINALLY. REPLACED WITH A SECOND BALLOON OF THE SAME PRODUCT/MODEL AND LOT NUMBER IMMEDIATELY. WHEN THE RATED BURST PRESSURE WAS 7 IT RUPTURED LONGITUDINALLY AGAIN. THE BALLOON DID NOT FRAGMENT WHEN IT BURST. THERE WAS NO INTERVENTION REQUIRED TO REMOVE THE BURST BALLOON FROM THE PATIENT. THE BURST BALLOON WAS RETRIEVED FROM PATIENT'S VESSEL. THE DEVICE WAS INTACT ON REMOVAL. THERE WAS NO VESSEL DAMAGE. THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER BRAND OF BALLOON IMMEDIATELY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12702968 ↗
• MalfunctionOct 27, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE THE FORTREX PTA BALLOON CATHETER DURING RENAL ACCESS PROCEDURE. THERE WAS NO LEAK NOTED AND NO LUER ADAPTER ISSUE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE FIRST BALLOON WAS FILLED TO THE RATED BURST PRESSURE OF 12 IN NORMAL USE. WHEN THE STENOSIS WAS FOUND NOT TO BE EXPANDED AND CONTINUED TO EXPAND IT WAS FILLED TO THE BURST PRESSURE OF 6 AND THE BALLOON RUPTURED LONGITUDINALLY. REPLACED WITH A SECOND BALLOON OF THE SAME PRODUCT/MODEL AND LOT NUMBER IMMEDIATELY. WHEN THE RATED BURST PRESSURE WAS 7 IT RUPTURED LONGITUDINALLY AGAIN. THE BALLOON DID NOT FRAGMENT WHEN IT BURST. THERE WAS NO INTERVENTION REQUIRED TO REMOVE THE BURST BALLOON FROM THE PATIENT. THE BURST BALLOON WAS RETRIEVED FROM PATIENT'S VESSEL. THE DEVICE WAS INTACT ON REMOVAL. THERE WAS NO VESSEL DAMAGE. THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER BRAND OF BALLOON IMMEDIATELY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12702967 ↗
• InjuryAug 18, 2020Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A FORTREX HP BALLOON DURING PATIENT TREATMENT. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. BALLOON DEFLATION DIFFICULTIES ARE REPORTED. IT IS REPORTED THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE. A CUT-DOWN WAS PERFORMED BY A VASCULAR SURGEON TO RETRIEVE THE BALLOON. NO FURTHER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10419421 ↗
• InjuryFeb 14, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A FISTULOGRAM, A FORTREX DEVICE BURST. THE PATIENT HAD A VENOTOMY TO REMOVE THE FRAGMENTS OF BALLOON BUT THIS WAS UNSUCCESSFUL. THE PATIENT WAS ADMITTED TO HOSPITAL AND TAKEN FOR A REPEAT FISTULOGRAM THE NEXT DAY. THE FRAGMENTS FROM THE FORTREX BALLOON WERE IN THE SUBCLAVIAN VEIN NEAR THE PROXIMAL STENT. A STENT WAS USED TO CAGE THE FRAGMENTS TO THE PATIENT'S VESSEL WALL.

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

  MAUDE report 8339230 ↗
• InjuryJan 24, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A FORTREX BALLOON WITH A NON-MEDTRONIC 7FR X 7CM SHEATH (BOSTON) AND A 0.035 WIRE (TERUMO GLIDEWIRE) TO TREAT A SLIGHTLY CALCIFIED FIBROUS LESION, SLIGHTLY TORTUOUS, WITH 80% STENOSIS DURING AVF ANGIOPLASTY IN THE PROXIMAL UPPER LEFT CEPHALIC VEIN. LESION LENGTH AND ARTERY DIAMETER WERE RESPECTIVELY 40MM AND 12 MM. THE DEVICE WAS PREPPED AS PER THE IFU AND NO ISSUES WERE NOTED. AN INFLATION DEVICE (BARD PRESTO) WAS USED. A CIRCUMFERENTIAL BALLOON BURST WAS REPORTED DURING INFLATION OF THE DEVICE AT 10 ATM. DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO RETRIEVE THE DEVICE FROM THE PATIENT AND THIS RESULTED IN SHAFT DETACHMENT. THE FRAGMENT MIGRATED TO THE UPPER ARM BASILICA VEIN. THE PHYSICIAN PLACED A NON-MEDTRONIC (BARD 12X60 COVERA) SELF-EXPANDING COVERED STENT IN THE ARM OF THE BALLOON EMBOLIZATION, ENTRAPPING THE BALLOON DISTAL TIP AND THE SHAFT. NO SNARE WAS ATTEMPTED DUE TO THE SIZE AND CONFIGURATION OF FRAGMENT AND RISK OF FURTHER EMBOLIZATION CENTRALLY. THE PATIENT'S FISTULA IS WORKING WELL.

  Patient problems: Device Embedded In Tissue or Plaque; Embolism

  MAUDE report 8273905 ↗
• InjuryJan 24, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  THE PHYSICIAN ATTEMPTED TO USE A FORTREX BALLOON WITH A NON-MEDTRONIC 7F X 7CM (BOSTON) AND A 0.035 GUIDEWIRE (BOSTON) TO TREAT A MODERATELY CALCIFIED FIBROUS LESION WITH 80% STENOSIS DURING AVF ANGIOPLASTY ACCESSED THROUGH THE PROXIMAL LEFT CEPHALIC ARCH WITH IN-STENT STENOSIS. LESION LENGTH AND ARTERY DIAMETER WERE RESPECTIVELY 40MM AND 12MM. THE DEVICE WAS INSPECTED PRIOR TO USE AND WAS REPORTED TO BE IN NORMAL AND ACCEPTABLE CONDITION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. AN INFLATION DEVICE WAS USED (BARD PRESTO). NO RESISTANCE WAS EXPERIENCED DURING THE ADVANCEMENT WITH THE DEVICE AND IT DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. A CIRCUMFERENTIAL BURST WAS REPORTED DURING DEVICE INFLATION AT 10 ATM. MANY ATTEMPTS WERE MADE VIA 2 ACCESS POINTS TO RETRIEVE THE BALLOON MATERIAL BUT THEY WERE NOT SUCCESSFUL (DIALYSIS ACCESS GRAFT THROMBOSIS AND OCCLUSION OCCURRED, RENDERING THE ACCESS NOT USABLE). THE BURST OF THE BALLOON AND SUBSEQUENT EMBOLIZATION OF THE LEFT-OVER BALLOON MATERIAL HAS LEFT THE PATIENT¿S DIALYSIS ACCESS GRAFT OCCLUDED. NO EXCESSIVE FORCE WAS USED. FRAGMENTS REMAINS IN PATIENT. NO ATTEMPT TO SNARE THE FRAGMENT WAS MADE BECAUSE THE

  Patient problems: Device Embedded In Tissue or Plaque; Embolism

  MAUDE report 8273558 ↗
• MalfunctionNov 28, 2018Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN USED A FORTREX BALLOON DURING TREATMENT OF A FIBROUS FISTULA IN MID LOCATION OF THE PATIENT¿S VESSEL. SLIGHT TORTUOSITY AND NO CALCIFICATION WERE REPORTED. NO DAMAGE WAS NOTED TO THE PACKAGING, NOR WERE ANY ISSUES EXPERIENCED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT A BALLOON BURST OCCURRED AT AN INFLATION PRESSURE OF 12ATM. IT IS UNKNOWN HOW MANY PRIOR INFLATIONS WERE APPLIED TO THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS ABORTED. THE BURST DID NOT CAUSE ANY PORTION OF THE BALLOON TO FRAGMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8109767 ↗