Passeo-18 6/200/130Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130430099), received between Jul 30, 2021 and Mar 25, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Decrease in Pressure” (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
- Decrease in Pressure2
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2025Material Rupture; Material Rupture
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION OF A SEVERELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN THE MID SFA. THE DEVICE WAS INSERTED AND INFLATED, BUT THE BALLOON RUPTURED JUST PRIOR TO REACHING 6 ATM. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21692829 ↗MalfunctionJul 30, 2021Decrease in Pressure; Decrease in Pressure
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. IT WAS ATTEMPTED TO INFLATE THE BALLOON UP TO 5 BAR, BUT TO KEEP IT AT 5 BAR IT WAS NECESSARY TO GIVE MORE PRESSURE. EVENTUALLY THE PASSEO-18 HAD TO BE REPLACED BY ANOTHER BALLOON AS IT COULD NOT BE USED ANYMORE. LOT NUMBER AND EVENT DATE ARE UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12252864 ↗MalfunctionJul 30, 2021Decrease in Pressure; Decrease in Pressure
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. IT WAS ATTEMPTED TO INFLATE THE BALLOON UP TO 5 BAR, BUT TO KEEP IT AT 5 BAR IT WAS NECESSARY TO GIVE MORE PRESSURE. EVENTUALLY THE PASSEO-18 HAD TO BE REPLACED BY ANOTHER BALLOON AS IT COULD NOT BE USED ANYMORE. LOT NUMBER AND EVENT DATE ARE UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12252848 ↗
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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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