Passeo-18 4/200/130Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07640130430075), received between Dec 14, 2021 and May 13, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (3 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
- Material Rupture3
- Failure to Advance1
- Fluid/Blood Leak1
- Fracture1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. IT WAS ATTEMPTED TO USE THE PASSEO-18 FOR PRE-DILATATION, BUT THE BALLOON COULD NOT BE INFLATED. AFTER REMOVAL OF THE DEVICE, A BALLOON LEAKAGE WAS DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22010994 ↗InjuryApr 15, 2025Fracture; Material Rupture; Fracture; Material Rupture
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE RIGHT SFA. THE BALLOON WAS INTRODUCED, BUT DURING INFLATION AT 12 ATM THE BALLOON WAS PIERCED DUE TO CALCIFICATION. THEN THE DEVICE WAS REMOVED, AND IT WAS NOTICED THAT THE DISTAL PART OF THE BALLOON WITH THE MARKER REMAINED IN THE TIP OF THE INTRODUCER. ALL DEVICES WERE REMOVED, BUT THE END OF THE BALLOON, WHICH WAS CRUMPLED, REMAINED BLOCKED IN THE LEFT FEMORAL ARTERY. DECISION WAS MADE TO PERFORM A BYPASS SURGERY TO REMOVE THE REMAINING BALLOON PART.
Patient problems: Insufficient Information
MAUDE report 21840128 ↗MalfunctionOct 18, 2023Failure to Advance; Failure to Advance
A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS PART OF THE FEMORAL ARTERY. THE COMPLAINT INSTRUMENT WAS INTRODUCED INTO THE PATIENTS BODY BUT COULD NOT PASS THE LESION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17959334 ↗MalfunctionDec 15, 2021Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON BURST DURING INFLATION AT 8 ATM.
Patient problems: Insufficient Information
MAUDE report 13010188 ↗MalfunctionDec 14, 2021Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON RUPTURED DURING THE SECOND INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13003020 ↗
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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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