FortrexRecalls & reported problems across all models
Medtronic, Inc. · 14 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 14 models of Fortrex by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Aug 7, 2024 and Sep 30, 2026 — classified as 4 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (25 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Fortrex problems
Device problems
- Burst Container or Vessel25
- Leak/Splash6
- Detachment of Device or Device Component4
- Component Missing2
- Difficult to Remove2
- Deflation Problem1
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- Insufficient Information2
Fortrex models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Fortrex™ A35HPV06040080Catheter, angioplasty, peripheral, transluminal10 reports
- Fortrex™ A35HPV05040080Catheter, angioplasty, peripheral, transluminal3 reports
- Fortrex™ A35HPV06040135Catheter, angioplasty, peripheral, transluminal3 reports
- Fortrex™ A35HPV08040080Catheter, angioplasty, peripheral, transluminal3 reports
- Fortrex™ A35HPV10040080Catheter, angioplasty, peripheral, transluminal3 reports
- Fortrex™ A35HPV06080080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV06080135Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV06100080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV07040080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV07100080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV08080080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV10080080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV12040080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV12080135Catheter, angioplasty, peripheral, transluminal1 report
Recent Fortrex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Leak/Splash
It was reported that intra-operatively, during inflation, the luer of a Fortrex PTA balloon catheter device was noted to be leaking. No damage was noted to the packaging and no issues were noted when removing the device from the tray/hoop. The device was prepped per IFU, with no issues identified. A new device was used to complete the procedure. No patient complications have been reported as a result of this event. Additional information: Based on review of the images the leak was coming from the shaft.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942834 ↗MalfunctionSep 2, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558288 ↗MalfunctionSep 2, 2026Burst Container or Vessel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558030 ↗MalfunctionAug 18, 2026Burst Container or Vessel
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50302171 ↗MalfunctionMar 26, 2026Burst Container or Vessel; Deflation Problem
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DRAINING VEIN PROCEDURE WITH A FORTREX 6.0MMX80MM BALLOON, INFLATION WAS PERFORMED TO A PRESSURE OF 23 ATM. THE BALLOON WAS SUDDENLY DEFLATED AND THE PRESSURE INDICATOR DROPPED TO ZERO. BLOOD WAS ASPIRATED FROM THE BALLOON INFLATION TUBE. UPON REMOVAL, A RUPTURE WAS FOUND IN THE DISTAL TIP OF THE BALLOON. VISUAL INSPECTION CONFIRMED THE RUPTURE. THE DEVICE WAS PREPPED PER THE IFU. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO PATIENT COMPLICATIONS OR INJURY HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701277 ↗MalfunctionJan 6, 2026Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING A FORTREX BALLOON FOR TREATMENT OF A FIBROUS LESION, A LONGITUDINAL BALLOON RUPTURE OCCURRED DURING BALLOON INFLATION AT A PRESSURE OF 20 ATM. A NON MEDTRONIC BALLOON INFLATION DEVICE WAS USED. NO RESISTANCE DURING ADVANCEMENT. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED BY REPLACING THE BALLOON WITH ANOTHER OF THE SAME BRAND AND MODEL TO ACHIEVE DILATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23973296 ↗MalfunctionDec 14, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING BALLOON INFLATION WITH THE FORTREX, LONGITUDINAL BURST OCCURRED AT THE BALLOON. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED. THE EVENT WAS OBSERVED AT AN INFLATION PRESSURE OF 20RBP. NO RESISTANCE WAS E NCOUNTERED WHEN ADVANCING THE DEVICE, AND NO EXCESSIVE FORCE WAS USED. THE PROCEDURE WAS COMPLETED BY REMOVING THE WHOLE SYSTEM. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799504 ↗MalfunctionDec 2, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash
IT WAS REPORTED THAT DURING THE USE OF THE FORTREX 08X040X80 BALLOON FOR A PROCEDURE, A BALLOON BURST, BALLOON LEAK OR CATHETER LEAK OCCURRED DURING THE FIRST INFLATION AT A PRESSURE OF 10 ATM. NO ISSUES WERE IDENTIFIED DURING PREPARATION OR REMOVAL FROM THE PACKAGING. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND NO EXCESSIVE FORCE WAS USED. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER FORTREX BALLOON. THERE WAS NO HARM OR INJURY TO THE PATIENT AS A RESULT OF THE EVENT AND NO INTERVENTION REQUIRED TO RETRIEVE THE BALLOON FRAGMENTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23694744 ↗MalfunctionNov 24, 2025Component Missing; Component Missing
IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A FORTEX BALLOON TO TREAT A LESION IN THE ILIAC ARTERY - COMMON. THE DEVICE WAS MISSING A MARKER POINT. A NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23630499 ↗MalfunctionNov 20, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash
IT WAS REPORTED THAT DURING A PROCEDURE USING THE 035 HPV 06X080X80, THERE WERE ALLEGATIONS OF BALLOON BURST/BALLOON LEAK/CATHETER LEAK. THE DEGREE OF CALCIFICATION WAS DESCRIBED AS MODERATE. THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605760 ↗MalfunctionNov 12, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING TREATMENT OF AN ARTERIOVENOUS (AV) FISTULA ON THE LEFT SIDE USING THE 10X40 FORTREX HP PTA BALLOON, THE BALLOON BURST ABOVE ITS RATED BURST PRESSURE AND DETACHED DURING THE EVENT. THE VESSEL WAS PRE-DILATED WITH AN 8X40 FORTREX HP PTA BALLOON. NOT ALL PIECES OR FRAGMENTS OF THE BALLOON WERE RETRIEVED FROM THE VESSEL, AND THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534557 ↗MalfunctionNov 12, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE FOR STENOSIS DILATION USING A FORTREX BALLOON CATHETER, BALLOON LEAKAGE AND BURST WERE OBSERVED DURING THE SECOND INFLATION AT A PRESSURE OF 22 ATM. THE PATIENT WAS TREATED FOR A FIBROUS LESION WITH NO TORTUOSITY OR CALCIFICATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534518 ↗MalfunctionNov 11, 2025Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE 035 HPV BALLOON, THERE WAS DIFFICULTY REMOVING THE BALLOON FOLLOWING BALLOON INFLATION. THE PROCEDURE WAS PERFORMED IN THE PROXIMAL SEGMENT OF THE LEFT CEPHALIC VEIN, TARGETING A FIBROUS LESION WITH MODERATE TORTUOSITY AND NO CALCIFICATION, USING A 6FR SHEATH AND A .035 TERUMO GUIDEWIRE. THE BALLOON WAS INFLATED WITH A BOSTON INFLATION DEVICE. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND NO EXCESSIVE FORCE WAS USED. AFTER ANGIOPLASTY, DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO INSERT THE DEVICE AGAIN, SO A BALLOON OF THE SAME SIZE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION 2025-OCT-30: THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT THROUGH THE SHEATH. NO INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23523355 ↗InjurySep 2, 2025Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A FIBROUS LESION IN THE PROXIMAL LEFT SUBCLAVIAN VESSEL USING THE FORTREX BALLOON, THE BALLOON BURST ABOVE ITS RATED BURST PRESSURE OF 19 ATM ON THE FIRST INFLATION. THE BURST WAS CIRCUMFERENTIAL/RADIAL, AND THE BALLOON DETACHED DURING THE PROCEDURE. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED FROM THE VESSEL USING A SNARE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW FORTREX DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22931818 ↗MalfunctionAug 18, 2025Component Missing; Component Missing
PHYSICIAN WAS ATTEMPTING TO USE FORTREX BALLOON TO TREAT PATIENT COMMON ILIAC ARTERY. IT WAS REPORTED THAT DEVICE WAS MISSING MARKER POINT. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22825914 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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