Passeo-18 5/80/90Recalls & 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 07640119558844), received between Oct 5, 2020 and Aug 7, 2025 — classified as 5 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
- Decrease in Pressure1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionJan 24, 2024Material Rupture; Material Rupture
A PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A HIGHLY RESISTANT STENOTIC LESION IN THE CEPHALIC VEIN (AV FISTULA). THE BALLOON INFLATED OUTSIDE OF THE SHEATH (CA. 10 CM FROM SHEATH). BALLOON BURST OCCURRED IMMEDIATELY WHEN BURST PRESSURE REACHED. THE BALLOON WAS REMOVED COMPLETELY WITHOUT ISSUES. ANOTHER PASSEO-18 WAS USED, AND THE TREATMENT COULD BE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18574498 ↗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 12252857 ↗MalfunctionNov 16, 2020Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION IN THE SUPERFICIAL FERMORAL ARTERY. THE PASSEO-18 BALLOON RUPTURED AT 6 ATM WITHOUT CAUSING ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10848377 ↗MalfunctionOct 5, 2020Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION IN THE SUPERFICIAL FERMORAL ARTERY. DURING THE ATTEMPT OF POSTDILATATION OF A STENT, THE PASSEO-18 BALLOON RUPTURED AT 6 ATM WITHOUT CAUSING ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10627964 ↗
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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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