Fortrex™ A35HPV08040080 (UDI 00763000106195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000106195), received between Jun 12, 2019 and Jul 8, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (9 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.

• MalfunctionJul 8, 2024Leak/Splash; Leak/Splash

  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 PR EPARATION, PROCEDURE, POST-PROCEDURE WITH AN ISSUE NOTED. 50/50 CONTRAST INFLATION FLUID WAS USED. IT WAS REPORTED A 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 19688612 ↗
• MalfunctionJun 18, 2024Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER DURING PTA SURGERY. IFU WAS FOLLOWED. INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. IT WAS REPORTED THAT THE BALLOON BURST AT THE DILATION SITE. THE PATIENT'S INTERNAL FISTULA BLOOD VESSEL INTIMA WAS NOT SMOOTH AND HAD CALCIFICATION POINTS, AND THE BALLOON BURST AT POINT WHERE PRESSURE WAS LOWER THAN THE MARKED BURST PRESSURE. THE PRESSURE AT TIME OF BURST IS UNCLEAR. THE BALLOON FRAGMENTED AND WAS COMPLETELY WITHDRAWN UNDER COLOR DOPPLER ULTRASOUND MONITORING, ALL FRAGMENTS WERE REMOVED FROM THE VESSEL WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO VESSEL INJURY WAS NOTED. THE INTERNAL FISTULA WAS UNOBSTRUCTED AND PROCEDURE WAS COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558699 ↗
• MalfunctionMay 15, 2024Nonstandard Device; Device Markings/Labelling Problem; Nonstandard Device; Device Markings/Labelling Problem

  A PHYSICIAN USED A FORTREX HP PTA BALLOON WITH A 6FR SHEATH AND AN 035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF THE PATIENTS BILIARY ARTERY. 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 WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES NOTED. SALINE INFLATION FLUID WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. EXCESSIVE FORCE WAS NOT USED. ACCORDING TO THE END-USER RECORD, A BALLOON WITH A DIAMETER SIZE OF 8MM WAS UTILIZED. THERE SEEMS TO BE A DISCREPANCY BETWEEN THE SIZE INDICATED ON THE PACKAGE (8MM) AND THE ACTUAL SIZE (5MM) PERCEIVED DURING THE PROCEDURE. PHYSICIAN INFLATED BALLOON UP TO 20ATM BUT STILL NOT REACH THE SIZE 8MM AS DESIRED. THE PROCEDURE WAS COMPLETED USING THE 5MM BALLOON AND PATIENT WAS DISCHARGED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19318043 ↗
• 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 RIGHT MID AV FISTULA IN UPPER ARM. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS NONE. LESION STENOSIS WAS 50%. EMBOLIC PROTECTION WAS NOT USED. BALLOON WAS INFLATED WITH A GENOSS 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. THERE WAS A CIRCUMFERENTIAL/RADIAL BALLOON BURST AT INFLATION UP TO 9 ATM (NOMINAL PRESSURE). ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936776 ↗
• MalfunctionSep 28, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON DURING PROCEDURE TO TREAT A LESION WITH SOFT TISSUE. AN UNKNOWN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE BALLOON RUPTURED WHEN THE BURST PRESSURE REACHED 20ATM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15500611 ↗
• MalfunctionJul 8, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A FORTREX BALLOON DILATATION DEVICE TO TREAT A PROX SUPERFICIAL FEMORAL ARTERY CALCIFIED LESION IN PATIENT WITH SEVERE TORTUOSITY. DEVICE WAS PREPPED AS PER IFU. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY, NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE BALLOON WAS ¿TEARED¿ BUT DID NOT DETACH IN PATIENT OR LEAK. ANOTHER BALLOON WAS USED. NO PATIENT INJURY WAS REPORTED FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14954590 ↗
• MalfunctionJun 30, 2022Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  A PHYSICIAN WAS USING A FORTREX BALLOON TO TREAT THE RIGHT SHORT SAPHENOUS VEIN (SSV) OF A PATIENT. THE TARGET LESION WAS A SOFT TISSUE LESION WITH NO TORTUOSITY AND LITTLE CALCIFICATION. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO EMBOLIC PROTECTION USED. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED. BALLOON INFLATION DIFFICULTIES WERE REPORTED. IT IS REPORTED THAT DURING THE INFLATION OF THE SURGICAL BALLOON, THE PRESSURE WAS SLOWLY INCREASED TO THE PREVIOUS ATMOSPHERIC PRESSURE, THE BALLOON RUPTURED WHEN INFLATED TO A PRESSURE OF 14ATM. THE BALLOON WAS REPLACED WITH A NEW BALLOON TO CONTINUE THE PRESSURE, AND THE OPERATION WAS COMPLETED. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14870659 ↗
• InjuryJan 21, 2021Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN USED A FORTREX HP BALLOON WITH A 7FR NON-MEDTRONIC SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 30MM FIBROUS FISTULA IN MID LOCATION WITHIN THE ARTERY. SLIGHT VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. ARTERY DIAMETER REPORTED AS 8MM. LESION EXHIBITED 90% STENOSIS. THERE WAS NO CALCIUM OR JAGGED PLAQUE PRESENT IN THE AREA OF ANGIOPLASTY. A MEDTRONIC EVEREST INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. A BALLOON BURST IS REPORTED DURING BALLOON INFLATION AT A PRESSURE OF 25ATM. 2 PRIOR INFLATIONS HAD BEEN APPLIED TO THE BALLOON. THE PHYSICIAN WAS AWARE THAT THE BALLOON WAS INFLATED PAST RBP. WHEN ATTEMPTING TO REMOVE THE BALLOON FOLLOWING THE BURST, DIFFICULTY WAS ENCOUNTERED WHEN TRYING TO REMOVE FROM THE SHEATH. THE PHYSICIAN WAS AWARE THAT THE BALLOON ONLY REQUIRED A 6FR SHEATH, BUT 7FR WAS USED. THE PHYSICIAN PULLED ON THE DEVICE AND THE CATHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11206904 ↗
• InjurySep 11, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON DURING PROCEDURE TO TREAT A LESION IN LEFT DISTAL OF AN UNKNOWN VESSEL WITH 75%. THE VESSEL DIAMETER AND LESION LENGTH ARE 8MM AND 40MM RESPECTIVELY. THE VESSEL WAS LITTLE TORTUOUS. THERE WAS NO DAMAGE TO DEVICE PACKAGING. THERE WAS NO ISSUE REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT DURING FIRST BALLOON INFLATION, CIRCUMFERENTIAL/RADIAL BURST AT 20 ATM OCCURRED. ALL FRAGMENTS OF THE BALLOON WAS NOT RETRIEVED. PERM CATH WAS IMPLANTED AFTER PATIENT DIALYSIS GRAFT SHUT DOWN. DIALYSIS GRAFT SHUT DOWN WITH A PORTION OF THE FORTREX REMAINING INSIDE THE PATIENT. PERM CATH WAS IMPLANTED AS A RESULT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Embolism

  MAUDE report 10520316 ↗
• MalfunctionApr 1, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE A FORTREX HP BALLOON DURING TREATMENT OF A FISTULA. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE BALLOON. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED A BALLOON BURST OCCURRED AT AN INFLATION PRESSURE OF 20ATM. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9910042 ↗
• MalfunctionJun 12, 2019Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A FORTREX 08X040X80 PTA BALLOON TO TREAT A NON CALCIFIED, NON TORTUOUS FIBROUS 80% STENOTIC LESION IN THE BASILIC OUTFLOW VEIN OF A/V LOOP GRAFT IN THE RIGHT FOREARM. THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 8MM & 2CM, RESPECTIVELY. 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. A 6FR SHEATH AND A 0.035 NON-MEDTRONIC GUIDEWIRE WERE USED WITH NO EMBOLIC PROTECTION. THE DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE WITH CONTRAST/SALINE SOLUTION WAS USED AS INFLATION FLUID. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED NOR EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. ON FIRST INFLATION TO 12ATM, THE BALLOON IS REPORTED TO HAVE RUPTURED. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. A SECOND BALLOON WAS USED WITHOUT INCIDENT TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8690905 ↗