Fortrex™ A35HPV12040080 (UDI 00763000106409)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000106409), received between Nov 22, 2018 and Sep 3, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (4 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.

• MalfunctionSep 3, 2024Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER WITH A 7FR SHEATH AND AN 035 GUIDEWIRE DURING 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 DEVICE WAS PREPPED PER THE IFU (INSTRUCTION FOR USE). EMBOLIC PROTECTION WAS NOT USED. 40/60 CONTRAST AND SALINE INFLATION FLUID WAS USED. IT WAS REPORTED THAT DURING NEGATIVE PREP SALINE LEAKED FROM THE SURFACE ON THE BALLOON WHEN IT WAS INFLATED INSIDE PATIENTS' BODY, A PINHOLE LEAK WAS REPORTED. ANOTHER FORTREX DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20124717 ↗
• MalfunctionJul 26, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER WITH A NON-MEDTRONIC (TERUMO) SHEATH AND A NON-MEDTRONIC (TERUMO) GUIDEWIRE DURING 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) FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. 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. A NON-MEDTRONIC (MERIT) INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 20/80 INFLATION FLUID WAS USED. IT WAS REPORTED THAT MARKERS WERE MISSING FROM THE BALLOON. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839875 ↗
• MalfunctionJan 21, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN INTENDED TO USE A FORTREX HP BALLOON DURING AN ARTERIOVENOUS FISTULA (AVF) TREATMENT. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU 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 BALLOON BURST OCCURRED DURING BALLOON INFLATION. NO BALLOON FRAGMENTS WERE LEFT IN THE PATIENT. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11206925 ↗
• InjuryDec 22, 2020Deflation Problem; Difficult to Remove; Detachment of Device or Device Component; Deflation Problem; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A FORTREX HP BALLOON WITH A NON-MEDTRONIC 7FR SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 30MM FIBROUS LESION IN THE PATIENT'S MID RIGHT BRACHIOCEPHALIC VEIN. SLIGHT VESSEL TORTUOSITY IS REPORTED. ARTERY DIAMETER REPORTED AS 11MM. LESION EXHIBITED 70% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKING. THE DEVICE WAS PREPPED WITHOUT ISSUE AS PER IFU. EMBOLIC PROTECTION WAS NOT USED. NO RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. A MEDTRONIC EVEREST INFLATION DEVICE WAS USED FOR BALLOON INFLATION WITH 50/50 CONTRAST AND NORMAL SALINE. DEFLATION ISSUES WERE NOTED DURING SUBSEQUENT INFLATION. IT IS REPORTED THE BALLOON WAS SLOW TO DEFLATE AT THE LESION SITE. DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO PULL THE BALLOON OUT THROUGH THE SHEATH AS IT WOULD NOT SMOOTHLY GO INTO THE SHEATH. THE PHYSICIAN APPLIED FORCE DURING REMOVAL ATTEMPT RESULTING IN THE TIP OF THE BALLOON TIP DETACHING. THE DISTAL SECTION OF THE BALLOON WAS REMOVED THROUGH THE SHEATH. A SNARE WAS THEN ATTEMPTED TO REMOVE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055162 ↗
• MalfunctionJul 1, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A FORTREX PTA BALLOON ALONG WITH NON-MEDTRONIC 9FR SHEATH AND 0.035" GUIDE WIRE DURING PROCEDURE TO TREAT A NONE CALCIFIED CENTRAL VEIN WITH 85% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH ARE 12MM AND 40MM RESPECTIVELY. MEDTRONIC INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THERE WAS NO DAMAGE TO DEVICE PACKAGING. THERE WERE NO ISSUES IDENTIFIED WHILE REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. ON FIRST INFLATION A LONGITUDINAL BURST OCCURRED AT 12ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE PASSED THROUGH A PREVIOUSLY IMPLANTED STENT. THERE WAS NO RESISTANCE WHILE ADVANCING THE DEVICE. ANOTHER BRAND BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10218702 ↗
• InjuryNov 22, 2018Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN INTENDED TO USE A FORTREX. IT WAS REPORTED THE BALLOON RUPTURED RADIALLY RESULTING IN THE BALLOON TURNING INSIDE OUT. IT IS REPORTED PARTICLES OF THE BALLOON REMAINED IN THE PATIENT. THE PHYSICIAN WAS UNABLE TO REMOVE THE PARTICLES FROM THE PATIENT. THE PATIENT WENT TO SURGERY TO HAVE THE BALLOON PARTICLES REMOVED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8098875 ↗