FortrexRecalls & reported problems across all models
Covidien LP · 34 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 121
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls
- 0
We found 34 models of Fortrex by Covidien LP in the FDA's device registry (GUDID). Together they are named in 121 adverse event reports in the FDA's MAUDE database, received between May 16, 2017 and Dec 14, 2025 — classified as 33 injuries, 88 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (91 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 Vessel91
- Leak/Splash17
- Detachment of Device or Device Component10
- Adverse Event Without Identified Device or Use Problem6
- Difficult to Remove6
- Inflation Problem6
- Device Markings/Labelling Problem4
- Nonstandard Device3
Patient problems
- No Clinical Signs, Symptoms or Conditions77
- No Consequences Or Impact To Patient24
- Device Embedded In Tissue or Plaque6
- Patient Problem/Medical Problem5
- Insufficient Information4
- Embolism3
- Occlusion2
- Thrombosis/Thrombus2
Fortrex models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Fortrex™ A35HPV06040080Catheter, angioplasty, peripheral, transluminal23 reports
- Fortrex™ A35HPV08040080Catheter, angioplasty, peripheral, transluminal11 reports
- Fortrex™ A35HPV12080080Catheter, angioplasty, peripheral, transluminal11 reports
- Fortrex™ A35HPV10040080Catheter, angioplasty, peripheral, transluminal9 reports
- Fortrex™ A35HPV08100080Catheter, angioplasty, peripheral, transluminal7 reports
- Fortrex™ A35HPV05040080Catheter, angioplasty, peripheral, transluminal6 reports
- Fortrex™ A35HPV12040080Catheter, angioplasty, peripheral, transluminal6 reports
- Fortrex A35HPV12040080Catheter, angioplasty, peripheral, transluminal6 reports
- Fortrex™ A35HPV06100080Catheter, angioplasty, peripheral, transluminal4 reports
- Fortrex™ A35HPV07040080Catheter, angioplasty, peripheral, transluminal4 reports
- Fortrex™ A35HPV08080080Catheter, angioplasty, peripheral, transluminal3 reports
- Fortrex A35HPV08040080Catheter, angioplasty, peripheral, transluminal3 reports
- Fortrex A35HPV10040080Catheter, angioplasty, peripheral, transluminal3 reports
- Fortrex™ A35HPV06080135Catheter, angioplasty, peripheral, transluminal2 reports
- Fortrex™ A35HPV09040080Catheter, angioplasty, peripheral, transluminal2 reports
- Fortrex™ A35HPV10080080Catheter, angioplasty, peripheral, transluminal2 reports
- Fortrex A35HPV07040080Catheter, angioplasty, peripheral, transluminal2 reports
- Fortrex™ A35HPV04020040Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV05080080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV06040135Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV06100135Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV07040135Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV07080080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV07100080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV07100135Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV08040135Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV08080135Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV09040135Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV09080080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV10080135Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex™ A35HPV12080135Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex A35HPV04040080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex A35HPV10080080Catheter, angioplasty, peripheral, transluminal1 report
- Fortrex A35HPV12080080Catheter, 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.
MalfunctionDec 14, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING NEGATIVE PREPARATION PRIOR TO INSERTION INTO THE PATIENT, A PIN HOLE LEAK WAS OBSERVED IN THE BALLOON OF THE FORTREX 10X040X80 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. THE TARGET LESION FOR TREATMENT WAS A CHRONIC TOTAL OCCLUSION (100% STENOSIS) OF THE PROXIMAL RIGHT SHORT SAPHENOUS VEIN, WITH MODERATE TORTUOSITY AND NO CALCIFICATION. THE BALLOON WAS INFLATEDUSING AN INFLATION DEVICE AT 4ATM. THE DEVICE WAS PREPPED PER INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED. THE PROCEDURE WAS COMPLETED BY REPLACING THE BALLOON WITH ANOTHER FROM THE SAME LOT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23799506 ↗InjuryAug 15, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE FORTREX BALLOON, A PATIENT WAS TREATED FOR AN 80% STENOSIS IN THE PROXIMAL LEFT ARM VEIN, WHICH EXHIBITED MODERATE CALCIFICATION AND MODERATE TORTUOSITY. ALLEGATIONS INCLUDED DEFORMATION OF THE CATHETER/DELIVERY SYSTEM, TWISTING AND BUNCHING OF THE DEVICE, AND RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE EXHIBITED ISSUES IN FRONT OF THE BALLOON TAIL MARKER POINT. A SURGICAL INCISION WAS REQUIRED TO REMOVE THE BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22813817 ↗MalfunctionJul 23, 2025Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN ATTEMPTED TO USE FORTREX BALLOON ALONG WITH A NON-MEDTRONIC SHEATH DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S LEFT DISTAL CEPHALIC VEIN. MODERATE CALCIFICATION AND LITTLE TORTUOSITY WERE REPORTED. ARTERY DIAMETER REPORTED AS 3MM AND LESION DIAMETER REPORTED AS 4MM. DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT A LONGITUDINAL BALLOON BURST OCCURRED AT 18ATM DURING INFLATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE RUPTURED BALLOON WAS REMOVED AND ANOTHER BALLOON WAS USED TO DILATE AND COMPLETED THE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22573894 ↗MalfunctionJul 8, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE FORTREX 05X040X80 DILATION BALLOON, THE PATIENT WAS BEING TREATED FOR A PLAQUE LESION WITH LITTLE TORTUOSITY AND CALCIFICATION IN THE DISTAL LEFT ARTERY. DURING THE SURGERY, WHEN THE BALLOON WAS DILATED TO 20PA, IT RUPTURED AND A LARGE AMOUNT OF BLOOD ENTERED THE PRESSURE PUMP. THE BALLOON WAS DIRECTLY REMOVED, AND THE PROCEDURE WAS COMPLETED AFTER REPLACING THE BALLOON WITH ANOTHER OF THE SAME MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22434605 ↗InjuryJul 4, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE FORTREX BALLOON DILATATION CATHETER AT THE DISTAL LEFT ARTERIOVENOUS FISTULA ANASTOMOSIS BETWEEN THE ARTERY AND CEPHALIC VEIN, A 60% SOFT TISSUE LESION STENOSIS WAS PRESENT. DURING BALLOON INFLATION WITH AN INFLATION DEVICE AT 23 ATM, A PIN HOLE RUPTURE OF THE BALLOON OCCURRED, RESULTING IN A BALLOON BURST. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. SUBSEQUENTLY, AN ARTERIOVENOUS ENDOLEAK AND FISTULA ARTERIOVENOUS VESSEL RUPTURE OCCURRED, WHICH WAS ADDRESSED BY PERFORMING A VASCULAR ANASTOMOSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Perforation of Vessels
MAUDE report 22402406 ↗InjuryJul 2, 2025Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN ATTEMPTED TO USE FORTREX BALLOON TREATMENT OF FIBROUS LESION IN PATIENTS RIGHT MID ARTERY/VEIN. MODERATE CALCIFICATION AND LITTLE TORTUOSITY WERE REPORTED. ARTERY DIAMETER REPORTED AS 4-6MM AND LESION DIAMETER REPORTED AS 60-80MM. EMBOLIC PROTECTION WAS USED AND INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT A BALLOON BURST OCCURRED AND IT WAS NOTED THAT PRESSURE WAS AT 20ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE BALLOON WAS REPLACED WITH A SMALLER ONE, BLOCKED THE BLOOD FLOW, AND CHANGED TO OPEN SURGERY FOR THROMBECTOMY AND DILATION. NO FUTHER PATIENT INJURY REPROTED FOR THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384951 ↗MalfunctionJun 19, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE FORTREX BALLOON, THERE WAS ABNORMAL PRESSURE OBSERVED WITH THE BALLOON, FOLLOWED BY A LONGITUDINAL RUPTURE DURING INFLATION AT 12 ATM. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE, AND ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED BY USING A NEW BALLOON. NO PATIENT SYMPTOMS, COMPLICATIONS, OR ADVERSE OUTCOMES WERE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289062 ↗MalfunctionJun 16, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE FORTREX 05 X 040 X 80 BALLOON, A PATIENT WITH PERIPHERAL ANASTOMOTIC STENOSIS AND A CALCIFIED TARGET LESION EXPERIENCED A PIN HOLE BALLOON BURST DURING BALLOON INFLATION AT 20 ATMOSPHERES. LITTLE VESSEL TORTUOSITY AND LITTLE VESSEL CALCIFICATION WERE REPORTED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED BY REPLACING THE BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22209984 ↗MalfunctionMar 12, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A FORTREX HIGH PRESSURE BALLOON DILATATION DEVICE FOR TREATMENT IN THE LEFT MID POPLITEAL ARTERY OF A PATIENT. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT A BALLOON PIN HOLE BURST OCCURRED DURING BALLOON INFLATION. IT WAS REPORTED THAT THIS OCCURRED AT 20ATMS. THE BALLOON WAS REPLACED. NO PATIENT INJURY REPORTED FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21582300 ↗MalfunctionFeb 19, 2025Inflation Problem; Leak/Splash; Difficult to Advance; Inflation Problem; Leak/Splash; Difficult to Advance
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING A FORTREX BALLOON, THERE WERE DIFFICULTIES INFLATING THE BALLOON, DUE TO A BALLOON LEAK. ADDITIONALLY, THERE WERE ISSUES WITH POOR GUIDEWIRE MOVEMENT, DIFFICULTIES LOADING OR EXCHANGING THE GUIDEWIRE, AND RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE INVOLVED THE RIGHT RADIAL ARTERY, SPECIFICALLY TARGETING A PROXIMAL FIBROUS LESION WITH 90% STENOSIS, MODERATE TORTUOSITY, AND LITTLE CALCIFICATION. THE ARTERY DIAMETER WAS 2.1 MILLIMETERS, AND THE LESION LENGTH WAS 5 MILLIMETERS. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE AT A PRESSURE OF 12 ATM, AND THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. THE PROCEDURE WAS COMPLETED BY REPLACING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21409811 ↗InjuryFeb 6, 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 INVOLVING A FORTREX HIGH PRESSURE BALLOON AT THE LEFT AV FISTULA, THE BALLOON BURST ABOVE THE RATED BURST PRESSURE OF 20 ATM ON THE FIRST INFLATION. THE BURST WAS NOTED TO BE LONGITUDINAL, AND THE BALLOON DETACHED DURING THE EVENT. THE DOCTOR USED A SNARE TO REMOVE THE BALLOON FRAGMENTS FROM THE PATIENT, AND NO EVIDENCE OF THE BALLOON WAS SEEN UNDER FLUOROSCOPY. THE LESION WAS IDENTIFIED AS FIBROUS, LOCATED MID TO DISTAL IN THE LEFT AV FISTULA, WITH A LESION LENGTH OF 80 CM. THE BALLOON WAS INFLATED USING A NON-MEDTRONIC INFLATION DEVICE WITH A 50/50 CONTRAST FLUID. THE PROCEDURE WAS COMPLETED AFTER THE DOCTOR SUCCESSFULLY REMOVED THE BALLOON FRAGMENTS USING THE SNARE. NO FURTHER PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21323939 ↗MalfunctionJan 15, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A FORTREX HIGH PRESSURE BALLOON DILATATION DEVICE FOR TREATMENT IN A PATIENT WITH CALCIFICATION. THE DEVICE WAS NOT PREPPED AS PER IFU. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT WAS REPORTED THAT A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED DURING BALLOON INFLATION AT 20 ATM, THE DEVICE WAS REPLACED AND NO PATIENT INJURY REPORTED FOR THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21159815 ↗MalfunctionJan 6, 2025Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER DURING PATIENT TREATMENT. A BALLOON BURST WAS REPORTED. FIRST INFLATION USED 24 ATMOSPHERES, THE SECOND INFLATION USED 20 ATMOSPHERES AND BALLOON RUPTURED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21077435 ↗MalfunctionNov 21, 2024Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER DURING TREATMENT OF ARTERIOVENOUS FISTULA STENOSIS IN A PATIENT. IT WAS REPORTED THAT DURING THE BALLOON DILATATION, WHEN THE PRESSURE WAS INCREASED TO 18ATM FOR THE SECOND TIME, THE BALLOON SUDDENLY RUPTURED. A REPLACEMENT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20744474 ↗MalfunctionNov 16, 2024Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem
PHYSICIAN ATTEMPTED TO USE A FORTREX HP PTA BALLOON CATHETER DURING TREATMENT OF THE PATIENT'S DISTAL RENAL ARTERY. THERE WERE NO ABN ORMALITIES REPORTED IN RELATION TO ANATOMY. 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) WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE FIRST INFLATION PRESSURE WAS ABOUT 12ATMS, AND THE BALLOON FAILED TOO FULLY OPEN. THE PATIENT WAS IN UNBEARABLE PAIN AND IT WAS DEFLATED. FOR THE SECOND INFLATION, PRESSURE WAS INCREASED TO 16 ATMS BUT PHYSICIAN SUDDENLY FELT DEFLATION. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED EXTRAVASATION OF CONTRAST AGENT, AND HEMATOMA WAS SEEN AT THE INFLATION SITE. AFTER THE BALLOON WAS SLOWLY PULLED OUT, IT WAS FOUND TO BE RUPTURED. A LONGITUDINAL BALLOON BURST WAS REPORTED DURING BALLOON INFLATION AT 16ATMS. A REPLACEMENT BALLOON WAS USED TO COMPRESS AND STOP BLEEDING AND THEN INFLATE AGAIN TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.
Patient problems: Hematoma; Pain
MAUDE report 20701272 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page