Passeo-18 5/40/130Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640119559063), received between Aug 7, 2025 and Aug 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).
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 Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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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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