Passeo-18Recalls & reported problems across all models
Biotronik AG · 54 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 169
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 54 models of Passeo-18 by Biotronik AG in the FDA's device registry (GUDID). Together they are named in 169 adverse event reports in the FDA's MAUDE database, received between Apr 23, 2019 and Aug 7, 2026 — classified as 4 injuries, 165 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (69 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-18 problems
Device problems
- Material Rupture69
- Fluid/Blood Leak33
- Material Puncture/Hole26
- Failure to Advance20
- Inflation Problem17
- Fracture10
- Decrease in Pressure5
- Difficult to Remove3
Patient problems
- No Clinical Signs, Symptoms or Conditions133
- No Consequences Or Impact To Patient29
- Insufficient Information4
- Failure of Implant1
- Foreign Body Embolism1
- No Known Impact Or Consequence To Patient1
Passeo-18 models
54 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Passeo-18 2/200/150Catheter, angioplasty, peripheral, transluminal11 reports
- Passeo-18 5/150/130Catheter, angioplasty, peripheral, transluminal10 reports
- Passeo-18 4/150/130Catheter, angioplasty, peripheral, transluminal9 reports
- Passeo-18 2.5/200/130Catheter, angioplasty, peripheral, transluminal8 reports
- Passeo-18 2/150/150Catheter, angioplasty, peripheral, transluminal7 reports
- Passeo-18 2.5/150/130Catheter, angioplasty, peripheral, transluminal7 reports
- Passeo-18 5/200/90Catheter, angioplasty, peripheral, transluminal7 reports
- Passeo-18 5/200/130Catheter, angioplasty, peripheral, transluminal7 reports
- Passeo-18 3/120/130Catheter, angioplasty, peripheral, transluminal6 reports
- Passeo-18 3/200/130Catheter, angioplasty, peripheral, transluminal6 reports
- Passeo-18 5/80/90Catheter, angioplasty, peripheral, transluminal5 reports
- Passeo-18 3/150/130Catheter, angioplasty, peripheral, transluminal5 reports
- Passeo-18 4/200/130Catheter, angioplasty, peripheral, transluminal5 reports
- Passeo-18 5/60/90Catheter, angioplasty, peripheral, transluminal4 reports
- Passeo-18 5/80/130Catheter, angioplasty, peripheral, transluminal4 reports
- Passeo-18 5/120/130Catheter, angioplasty, peripheral, transluminal4 reports
- Passeo-18 2/40/150Catheter, angioplasty, peripheral, transluminal4 reports
- Passeo-18 2/120/150Catheter, angioplasty, peripheral, transluminal4 reports
- Passeo-18 2/170/150Catheter, angioplasty, peripheral, transluminal4 reports
- Passeo-18 4/80/130Catheter, angioplasty, peripheral, transluminal3 reports
- Passeo-18 6/120/130Catheter, angioplasty, peripheral, transluminal3 reports
- Passeo-18 6/200/130Catheter, angioplasty, peripheral, transluminal3 reports
- Passeo-18 3/40/90Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-18 4/40/90Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-18 4/40/130Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-18 6/40/130Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-18 5/60/130Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-18 2.5/120/130Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-18 2.5/170/130Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-18 3/170/130Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-18 2/80/90Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-18 2/60/150Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-18 2/80/150Catheter, angioplasty, peripheral, transluminal2 reports
- Passeo-18 3/20/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 2.5/40/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 7/40/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 4/60/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 6/60/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 2.5/80/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 6/80/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 3/120/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 4/120/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 3/40/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 5/40/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 6/60/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 3/80/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 4/120/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 2/40/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 2/120/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 3/60/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 6/80/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 6/150/130Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 4/200/90Catheter, angioplasty, peripheral, transluminal1 report
- Passeo-18 6/200/90Catheter, angioplasty, peripheral, transluminal1 report
Recent Passeo-18 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2026Failure to Unfold or Unwrap
The Passeo-18 peripheral balloon catheter was selected for treatment of a severely calcified lesion in a moderately tortuous segment of the SFA. The balloon inflated only proximally and failed to fully expand despite inflation to 4 atm and reinflation attempts. The balloon was removed and replaced with another balloon of the same size, which functioned normally without any issues.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173434 ↗MalfunctionMar 25, 2026Material Deformation
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (80% STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE FEMORAL ARTERY. DURING CATHETER ADVANCEMENT, THE DISTAL END OF THE BALLOON WAS DAMAGED AND DEFORMED, PREVENTING IT FROM INFLATION AND EXPANSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24684505 ↗MalfunctionMar 5, 2026Material Rupture
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION IN A MILDLY TORTUOUS SEGMENT OF THE MID ANTERIOR TIBIAL ARTERY. THE BALLOON RUPTURED DURING THE ATTEMPT TO INFLATE IT UP TO 6 ATM. A PASSEO-14 WAS USED AS A REPLACEMENT WITH NO ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518957 ↗MalfunctionFeb 3, 2026Material Rupture
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE LEFT SFA. THE BALLOON RUPTURED PRIOR TO NOMINAL PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24245350 ↗MalfunctionJan 29, 2026Material Puncture/Hole; Material Rupture
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE PROXIMAL ANTERIOR TIBIAL ARTERY. THE DEVICE WAS INTRODUCED FOR AN ANGIOPLASTY PROCEDURE, BUT IT BURST BEFORE REACHING NOMINAL PRESSURE. THE BURST BALLOON WAS REMOVED AND REPLACED BY A BALLOON FROM ANOTHER COMPANY, WHICH WAS SUCCESSFULLY INFLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209608 ↗MalfunctionDec 16, 2025Material Rupture; Material Rupture
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (85% STENOSIS DEGREE) IN A SEVERELY TORTUOUS PART OF THE MID SFA. DURING INFLATION OF THE DEVICE THE BALLOON RUPTURED. THE DEVICE WAS WITHDRAWN AND NO PART REMAINS IN BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23814394 ↗MalfunctionNov 28, 2025Material Rupture; Material Rupture
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS PART OF THE LEFT SFA. THE AFFECTED DEVICE WAS POSITIONED IN THE LESION AND INFLATED BUT THE BALLOON BURST PRIOR TO REACHING RBP. THE PRESSURE WAS NOT RECORDED. THE AFFECTED DEVICE WAS WITHDRAWN. ANOTHER BALLOON CATHETER WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23671259 ↗MalfunctionNov 14, 2025Material Rupture; Material Rupture
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (>80 % STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE POPLITEAL ARTERY. THE AFFECTED DEVICE WAS POSITIONED IN THE TARGET LESION AND INFLATED TO 5 ATM DURING WHICH THE BALLOON BURST. THE AFFECTED DEVICE WAS SUCCESSFULLY WITHDRAWN. AFTER ADDITIONAL CORRESPONDENCE WITH THE LOCAL STAFF, IT WAS CONFIRMED THAT THE DEVICE DID NOT LEAK DURING INFLATION. UNFORTUNATELY, THE DEVICE IS NO LONGER AVAILABLE AS IT WAS DISPOSED OF DUE TO BLOOD CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23553021 ↗MalfunctionNov 13, 2025Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (50% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE DISTAL ANTERIOR TIBIAL ARTERY. THE SYSTEM WAS PURGED AND INTRODUCED VIA A 6 F TERUMO INTRODUCER TO PERFORM ANGIOPLASTY OF THE ANTERIOR TIBIAL ARTERY. UPON INJECTION OF CONTRAST, IT WAS NOTED THAT THE BALLOON COULD NOT BE INFLATED. THE BALLOON WAS SUBSEQUENTLY WITHDRAWN, AND WHEN TESTED OUTSIDE THE PATIENT, CONTRAST LEAKAGE WAS OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23541267 ↗MalfunctionOct 10, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. THE BALLOON COULD NOT REACH THE NBP WHEN INFLATE IN THE LESION. AFTER REMOVAL OF THE DEVICE, A BALLOON LEAKAGE WAS DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23263304 ↗MalfunctionSep 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION WITH 70% STENOSIS DEGREE. THE DEVICE WAS DELIVERED TO THE LESION BUT COULD NOT BE INFLATED. IT WAS NOTICED AFTER WITHDRAWAL THAT THE BALLOON WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23119634 ↗MalfunctionSep 8, 2025Entrapment of Device; Entrapment of Device
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (50% STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF AN UNKNOWN VESSEL. AFTER BALLOON INFLATION WITHIN THE VESSEL, RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO WITHDRAW THE PASSEO-18 THROUGH THE FORTRESS DEVICE. THE SYSTEMS WERE REMOVED AS A UNIT, AND THE BALLOON WAS CUT AT THE PROXIMAL SHAFT TO REMOVE IT FROM THE SHEATH. AFTER RE-INSERTION OF THE FORTRESS, THE PROCEDURE WAS THEN CONTINUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22991800 ↗MalfunctionAug 7, 2025Material Puncture/Hole; Material Puncture/Hole
PASSEO-18 BALLOON CATHETERS WERE SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. TWO BALLOONS RUPTURED. THEY COULD NOT EVEN BE INFLATED UP TO MAXIMUM PRESSURE BEFORE THE BALLOONS RUPTURED AT 8 ATM. THIS REFERS TO 2ND BALLOON, THE OTHER BALLOON IS REPORTED SEPARATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22735467 ↗MalfunctionAug 7, 2025Material Puncture/Hole; Material Puncture/Hole
PASSEO-28 BALLOON CATHETERS WERE SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. TWO BALLOONS RUPTURED. THEY COULD NOT EVEN BE INFLATED UP TO MAXIMUM PRESSURE BEFORE THE BALLOONS RUPTURED AT 8 ATM. THIS REFERS TO 1ST BALLOON, THE OTHER BALLOON IS REPORTED SEPARATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22735415 ↗MalfunctionJul 23, 2025Failure to Advance; Failure to Advance
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL SUBCLAVIAN ARTERY. AN ACCESS WAS MADE WITH A 5F INTRODUCER SHEATH THROUGH THE RIGHT FEMORAL ARTERY. A FIRST ATTEMPT WAS MADE TO CROSS THE LESION WITH A GUIDE WIRE BUT WAS UNSUCCESSFUL. THE GUIDEWIRE WAS CHANGED TO A 0.018" GUIDE WIRE TOGETHER WITH A "SINGLE BEND" SUPPORTING CATHETER BUT THE TARGET LESION COULD NOT BE CROSSED. FOLLOWING, THE COMPLAINT DEVICE WAS INSERTED OVER THE 0.018" GUIDE WIRE. AN INITIAL ATTEMPT TO CROSS THE TARGET LESION IN THE SUBCLAVIAN ARTERY FAILED. AFTER "REPEATED MANEUVERS" (NO FURTHER INFORMATION ABOUT THE MANEUVERS OR DEVICES USED WERE GIVEN) IT WAS POSSIBLE TO CROSS THE LESION WITH THE GUIDE WIRE. THE COMPLAINT DEVICE WAS THEN ADVANCED IN STEPS OVER THE TARGET LESION AND THE TARGET LESION WAS "DILATED SLOWLY" UNTIL A FLOW WAS ESTABLISHED IN THE DISTAL SUBCLAVIAN ARTERY. THEREAFTER, THE COMPLAINT DEVICE WAS WITHDRAWN. THE SUBCLAVIAN ARTERY WAS FURTHER DILATED BY DIFFERENT OTHER BALLOON CATHETERS. AFTER THESE BALLOONS AN ADDITIONAL DRUG ELUTING STENT WAS IMPLANTED IN THE SUBCLAVIAN ARTERY AND THE FLOW WAS FUL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574650 ↗
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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