Passeo-14Recalls & reported problems across all models
Biotronik AG · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 13 models of Passeo-14 by Biotronik AG in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Oct 29, 2019 and Nov 21, 2025 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. 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-14 problems
Device problems
- Fluid/Blood Leak9
- Material Puncture/Hole5
- Inflation Problem3
- Material Rupture3
- Fracture2
- Deflation Problem1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient1
Passeo-14 models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Passeo-14 2/220/150Catheter, angioplasty, peripheral, transluminal4 reports
- Passeo-14 1.5/70/150Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-14 2.5/70/150Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-14 2/140/150Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-14 2.5/140/150Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-14 3.5/40/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-14 1.5/20/150Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-14 1.5/40/150Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-14 2/40/150Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-14 4/40/150Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-14 2/70/150Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-14 2.5/220/150Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-14 3/220/150Catheter, angioplasty, peripheral, transluminal1 report
Recent Passeo-14 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2025Difficult to Remove; Difficult to Remove
THE PASSEO-14 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR DILATATION OF A MILDLY CALCIFIED LESION IN THE MID ANTERIOR TIBIAL ARTERY (ATA). DIFFICULTIES OCCURRED WHILE PULLING OUT THE BALLOON CATHETER FROM THE SHEATH AFTER DEFLATION. AFTER PULLING OUT THE DEVICE, IT WAS DETECTED THAT THE STIFFENING WIRE CAME OUT FROM THE DISTAL SHAFT NEAR THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23616461 ↗MalfunctionJan 16, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE PASSEO-14 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR DILATATION OF A MILDLY CALCIFIED LESION IN THE MID ANTERIOR TIBIAL ARTERY (ATA). THE BALLOON WAS POSITIONED AT PROXIMAL PART OF THE ATA LESION AND INFLATED UP TO RATED BURST PRESSURE TWICE. IT LEAKED DURING THIRD INFLATION AT 10 ATM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21170293 ↗MalfunctionJan 2, 2025Material Rupture; Material Rupture
THE PASSEO-14 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE LEFT SFA. THE PASSEO-14 BALLOON CATHETER RUPTURED DURING INFLATION BEFORE REACHING THE NOMINAL PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21063181 ↗MalfunctionNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE PASSEO-14 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE DEVICE WAS ADVANCED INTO THE TARGET LESION AND WAS INFLATED AS USUAL BUT THE BALLOON WOULD NOT HOLD PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20782726 ↗MalfunctionAug 21, 2024Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem
THE PASSEO-14 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR DILATATION OF A MID TO DISTAL ATA STENOSIS. THE PASSEO-14 WAS POSITIONED AT THE MID ATA AND READY TO BE INFLATED. IT WAS NOTICED THAT THE BALLOON WAS NOT ABLE TO BE INFLATED AS THE PRESSURE WAS NOT ABLE TO BE BUILD UP WHEN TURNING THE INFLATION DEVICE. THE BALLOON WAS THEN FULLY REMOVED AND REPLACED WITH ANOTHER PASSEO-14 TO CONTINUE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20010612 ↗MalfunctionJan 18, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE PASSEO-14 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MILDLY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE MID TIBIAL ARTERY. THE AFFECTED DEVICE WAS INTRODUCED, AND A HUB LEAKAGE WAS DETECTED. DURING THE TECHNICAL INVESTIGATION A BALLOON PINHOLE WAS OBSERVED. THE PINHOLE DID NOT OCCUR DUE TO THE REPORTED COMPLAINT EVENT. THE HUB LEAKAGE WAS DETECTED BY THE PHYSICIAN, BUT THE PINHOLE REMAINED UNDETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18535660 ↗MalfunctionJan 3, 2024Material Puncture/Hole; Material Puncture/Hole
THE PASSEO-14 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MILDLY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE MID TIBIAL ARTERY. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENTS BODY AND ADVANCED TO THE AREA OF INTEREST. ONCE POSITIONED, THE BALLOON WAS INFLATED WITH A MAXIMUM PRESSURE OF 8 ATM. THEREAFTER, THE 0.014 INCH GUIDEWIRE WAS REMOVED. THE PHYSICIAN TOOK A 3CC SYRINGE WITH 0.5 ML CONTRAST MEDIUM AND 2 ML SALINE AND INJECTED THE SOLUTION THROUGH THE GUIDEWIRE PORT DURING WHICH THE SOLUTION WAS SEEN TO EMERGE FROM THE BALLOON PORT OF THE AFFECTED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18437194 ↗MalfunctionJun 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE PASSEO-14 BALLOON CATHETER WAS CHOSEN FOR PTA OF A LOWER LEG BLOOD VESSEL. IT WAS REPORTED THAT THE GUIDEWIRE (NO FURTHER INFORMATION AVAILABLE) CAME OUT OF THE SIDE PORT INSTEAD OUT OF THE GUIDEWIRE LUMEN OF THE COMPLAINT INSTRUMENT. THUS, A CONNECTION BETWEEN THE GUIDEWIRE LUMEN AND THE INFLATION LUMEN WAS SUSPECTED. THIS WAS NOTED AFTER USING THE BALLOON SEVERAL TIMES WHEN THE DISTAL PORTION OF THE GUIDEWIRE WAS STILL INSIDE THE PATIENTS BODY WHILE THE DEFECTIVE PART OF THE INSTRUMENT WAS OUTSIDE OF THE PATIENTS BODY. DURING THE PREPARATIONS FOR THE INTERVENTION, THE COMPLAINT INSTRUMENT COULD BE NORMALLY FLUSHED. THE PASSEO-14 WAS USED AS USUAL IN A STANDARD WAY AND NO HIGH PRESSURE DEVICE WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17128274 ↗MalfunctionApr 12, 2023Fluid/Blood Leak; Fluid/Blood Leak
A PASSEO-14 BALLOON CATHETER WAS CHOSEN FOR TREATMENT, BUT IT WAS NOT POSSIBLE TO INSERT THE GUIDEWIRE INTO THE LUMEN OF THE BALLOON CATHETER. THUS, THE PASSEO 14 PTA CATHETER WAS FLUSHED FOR A SECOND TIME WITH NACL. HOWEVER, THE NACL CAME OUT OF THE BALLOON LUMEN AND A LEAKAGE WAS DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16724987 ↗MalfunctionFeb 28, 2023Material Rupture; Material Rupture
A PASSEO-14 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. WHEN INFLATING THE BALLOON UP TO 4.5 BAR, THE BALLOON CRACKED, ALTHOUGH NO CALCIFICATION WAS SEEN IN THE VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16451912 ↗MalfunctionDec 21, 2022Material Rupture; Material Rupture
THE PASSEO-14 BALLOON CATHETER WAS SELECTED FOR TREATMENT IN A DISTAL TIBIAL ARTERY. THE BALLOON RUPTURED. THE PHYSICIAN DID NOT TAKE PAST RBP BUT DID INFLATE PRIOR TO ATHERECTOMY TO MAKE WAY FOR DEVICE. HE IS PRE-DILATING AND INFLATES FAST STRAIGHT TO NOMINAL AND/OR BEYOND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16020171 ↗MalfunctionDec 15, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE PASSEO-14 BALLOON CATHETER WAS SELECTED FOR TREATMENT. THE PASSEO-14 BALLOON COULD NOT BE INFLATED AS IT REACHED THE LESION BELOW THE KNEE. UPON REMOVAL A LEAKAGE WAS FOUND IN THE BALLOON, AND ANOTHER DEVICE WAS USED FOR THE PROCEDURE. THE BALLOON WAS SCRAPPED BY THE HOSPITAL AND COULD NOT BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15986441 ↗MalfunctionDec 7, 2022Material Puncture/Hole; Material Puncture/Hole
THE PASSEO-14 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION IN THE POSTERIOR TIBIAL ARTERY. THE DEVICE WAS INTRODUCED INTO PATIENTS BODY AND INFLATED. DURING SECOND INFLATION AFTER TWO MINUTES AT NOMINAL PRESSURE THE BALLOON RUPTURED. ANOTHER BALLOON WAS SUCCESSFULLY USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15931523 ↗MalfunctionDec 7, 2022Material Puncture/Hole; Material Puncture/Hole
THE PASSEO-14 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION IN THE POSTERIOR TIBIAL ARTERY. THE DEVICE WAS INTRODUCED INTO PATIENTS BODY AND INFLATED. DURING SECOND INFLATION AFTER THREE MINUTES AT NOMINAL PRESSURE THE BALLOON RUPTURED. ANOTHER BALLOON WAS SUCCESSFULLY USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15931449 ↗MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE PASSEO-14 BALLOON CATHETER WAS USED FOR PRE-DILATATION OF A MODERATELY CALCIFIED LESION WITH 70 PERCENT STENOSIS DEGREE, BUT THE BALLOON COULD NOT BE INFLATED AND A LEAKAGE WAS FOUND AFTER WITHDRAWAL. ANOTHER BALLOON WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15433425 ↗
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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