Passeo-35Recalls & reported problems across all models
Biotronik AG · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 24 models of Passeo-35 by Biotronik AG in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between May 8, 2019 and Dec 11, 2024 — classified as 1 injury, 35 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (16 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 Passeo-35 problems
Device problems
- Material Rupture16
- Fluid/Blood Leak6
- Inflation Problem6
- Difficult to Remove3
- Material Puncture/Hole3
- Failure to Advance2
- Leak/Splash2
- Activation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient5
- Insufficient Information2
- Injury1
- Pain1
Passeo-35 models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Passeo-35 6/40/80CATHETER, PERCUTANEOUS3 reports
- Passeo-35 4/150/130Catheter, angioplasty, peripheral, transluminal3 reports
- Passeo-35 7/40/80CATHETER, PERCUTANEOUS2 reports
- Passeo-35 8/40/80CATHETER, PERCUTANEOUS2 reports
- Passeo-35 5/60/80CATHETER, PERCUTANEOUS2 reports
- Passeo-35 5/40/130CATHETER, PERCUTANEOUS2 reports
- Passeo-35 6/40/130CATHETER, PERCUTANEOUS2 reports
- Passeo-35 8/80/130CATHETER, PERCUTANEOUS2 reports
- Passeo-35 3/80/90Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-35 6/150/90Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-35 10/40/80CATHETER, PERCUTANEOUS1 report
- Passeo-35 7/60/80CATHETER, PERCUTANEOUS1 report
- Passeo-35 7/40/130CATHETER, PERCUTANEOUS1 report
- Passeo-35 6/60/130CATHETER, PERCUTANEOUS1 report
- Passeo-35 6/120/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 10/40/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 10/60/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 10/80/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 4/100/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 5/120/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 6/120/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 5/150/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 6/150/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-35 5/200/130Catheter, angioplasty, peripheral, transluminal1 report
Recent Passeo-35 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2024Material Rupture; Material Rupture
THE PASSEO-35 BALLOON RUPTURED DURING THE INTERVENTION. UPON REMOVAL, PART OF THE BALLOON WAS LOST. FURTHER INFORMATION IS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20906635 ↗MalfunctionDec 11, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE PASSEO-35 BALLOON SYSTEM WAS SELECTED FOR PRE-DILATATION OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS PROXIMAL SFA, BUT THE BALLOON WAS LEAKING DURING INFLATION. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20906050 ↗MalfunctionMay 24, 2024Material Rupture; Material Rupture
A PASSEO-35 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (STENOSIS DEGREE: 90 PERCENT) IN THE MILDLY TORTUOUS MID LEFT UPPER LIMB VEIN. DURING EXPANSION AND WHEN THE PRESSURE REACHED 12 KPA, THE PASSEO-35 BALLOON RUPTURED BUT DID NOT REACH THE MAXIMUM PRESSURE FOR THAT CATHETER (14 KPA). THE PATIENT REPORTED SIGNIFICANT PAIN IN THE LEFT FOREARM, AND THE BALLOON WAS REPLACED TO CONTINUE THE PROCEDURE.
Patient problems: Pain
MAUDE report 19393845 ↗MalfunctionApr 29, 2024Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem
A PASSEO-35 WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (STENOSIS DEGREE: 80 PERCENT) IN THE MODERATELY TORTUOUS MID ARTERIOVENOUS FISTULA. THE PATIENT WAS PREPARED, AND GUIDEWIRE WAS INSERTED, FOLLOWED BY THE INSERTION OF THE PASSEO-35 BALLOON FOR PRE-DILATATION. HOWEVER, THE BALLOON FAILED TO INFLATE PROPERLY. IT COULD NOT BE INFLATED TO THE NOMINAL PRESSURE. THE BALLOON WAS WITHDRAWN AND REPLACED WITH THE SAME MODEL AND INFLATED NORMALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19207948 ↗MalfunctionDec 14, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT. THE BALLOON CATHETER WAS POSITIONED IN THE TARGET LESION, BUT COULD ONLY BE INFLATED UP TO 7-9 ATM, NOT FULLY INFLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18330926 ↗MalfunctionNov 28, 2023Material Rupture; Material Rupture
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN AN AV FISTULA. THE DEVICE WAS USED FOR PRE-DILATATION, BUT THE BALLOON COULD NOT BE INFLATED ANYMORE WHEN IT REACHED 6 ATM. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18219428 ↗MalfunctionOct 25, 2023Material Rupture; Material Rupture
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF AN ARTERIOVENOUS FISTULA. THE DEVICE WAS ADVANCED TO THE LESION AND WHEN STARTING TO INFLATE THE BALLOON UP TO 12 ATM, WHEN BALLOON RUPTURED. THE DEVICE WAS WITHDRAWN AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS DISCHARGED HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18004680 ↗MalfunctionOct 18, 2023Failure to Advance; Failure to Advance
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION IN THE MODERATELY TORTUOUS MID SFA. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17959335 ↗MalfunctionSep 15, 2023Fluid/Blood Leak; Fluid/Blood Leak
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT. DURING ATTEMPT TO DILATE AN ARTERIOVENOUS FISTULA, THE BALLOON COULD NOT BE INFLATED, AND A LEAKAGE WAS DETECTED. THE DEVICE WAS WITHDRAWN, AND ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17755392 ↗MalfunctionSep 15, 2023Material Rupture; Material Rupture
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE SFA. THE DEVICE WAS DELIVERED TO THE LESION, BUT THE BALLOON RUPTURED DURING INFLATION. THE DEVICE WAS SUCCESSFULLY WITHDRAWN.
Patient problems: Insufficient Information
MAUDE report 17755389 ↗MalfunctionSep 15, 2023Inflation Problem; Inflation Problem
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT. DURING ATTEMPT TO DILATE AN ARTERIOVENOUS FISTULA, THE BALLOON COULD NOT BE INFLATED, AND THE DEVICE WAS WITHDRAWN. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17755378 ↗MalfunctionSep 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION WITH 80 PERCENT STENOSIS DEGREE IN THE MODERATELY TORTUOUS SFA. THE BALLOON EASILY REACHED THE LESION WITHOUT RESISTANCE AND WITHOUT USING FORCE. WHEN THE BALLOON INFLATION WAS ATTEMPTED, THERE WAS NO READING ON THE ATM DIAL AND THE BALLOON WAS NOT INFLATING ON FLUORO. IT WAS NOTICED THAT THE INFLATION FLUID WAS IN FACT LEAKING OUT OF THE WIRE LUMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17735781 ↗MalfunctionMay 17, 2023Material Rupture; Material Rupture
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT. DURING PRE-DILATATION OF A MODERATELY CALCIFIED LESION WITH 95PERCENT STENOSIS DEGREE, THE BALLOON RUPTURED. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16946616 ↗MalfunctionApr 20, 2023Inflation Problem; Inflation Problem
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION IN A CENTRAL VEIN. IT WAS NOT POSSIBLE TO INFLATE THE PASSEO-35 BALLOON CATHETER. THE BALLOON WAS WITHDRAWN, AND ANOTHER STENT WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16779264 ↗MalfunctionOct 27, 2022Failure to Advance; Failure to Advance
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN THE LEFT MID SFA. AFTER ADVANCING THE PASSEO-35 OVER THE GUIDEWIRE, THE DEVICE COULD NOT PASS THE LESION DESPITE SEVERAL ATTEMPTS. THE DEVICE WAS WITHDRAWN AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS STABLE AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15679503 ↗
Other Biotronik AG products
All Biotronik AG devices →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.
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