Passeo-18 3/150/130Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-18 (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130414730), received between Apr 23, 2020 and Jul 21, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (2 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Advance2
- Fluid/Blood Leak2
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (70 % STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE PROXIMAL SFA. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY AND POSITIONED ACCORDINGLY BUT THE BALLOON COULD NOT BE INFLATED. AFTER DEVICE WITHDRAWAL, A LEAKAGE WAS OBSERVED. ANOTHER BALLOON WAS USED TO SUCCESSFULLY FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553027 ↗MalfunctionSep 16, 2024Failure to Advance; Failure to Advance
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION OF A SEVERELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS OSTIAL RIGHT SFA. DESPITE PRE-DILATATION, THE LESION COULD NOT BE CROSSED WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20225495 ↗MalfunctionJan 12, 2024Inflation Problem; Inflation Problem
A PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION OF A LESION WITH 75 PERCENT STENOSIS DEGREE IN THE RIGHT SFA, BUT THE BALLOON COULD NOT BE INFLATED AFTER REACHING THE LESION. THE PRESSURE WAS VERY LOW AND DID NOT RECORD. ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18502333 ↗MalfunctionSep 2, 2022Failure to Advance; Failure to Advance
A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED 158MM LONG LESION WITH 70 PERCENT STENOSIS DEGREE. THE DEVICE COULD NOT PASS THE LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15349652 ↗MalfunctionApr 23, 2020Fluid/Blood Leak; Fluid/Blood Leak
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION IN THE MID SFA. DURING FLUSHING THE GUIDE WIRE LUMEN A BALLOON LEAKAGE WAS NOTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9992977 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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