Passeo-18 5/120/130Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640119559223), received between Jun 2, 2022 and Mar 30, 2023 — classified as 4 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.
Most reported problems
Device problems
- Failure to Advance2
- Material Puncture/Hole2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2023Failure to Advance; Failure to Advance
THE PASSEO-18 BALLOON CATHETER WAS CHOSEN TO CONDUCT THE PRE-DILATATION OF A MILDLY CALCIFIED LESION WITH 90 PERCENT STENOSIS DEGREE IN THE MODERATELY TORTUOUS SFA, BUT THE LESION COULD NOT BE PASSED WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16645720 ↗MalfunctionFeb 28, 2023Failure to Advance; Failure to Advance
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS OSTIAL FEMORAL ARTERY. THE LESION COULD NOT BE CROSSED WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16451913 ↗MalfunctionJun 2, 2022Material Puncture/Hole; Material Puncture/Hole
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR PRE-DILATATION OF A MODERATELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS SFA. DURING INFLATION UP TO 6 ATM, IT WAS NOTED THAT CONTRAST MEDIUM WAS LEAKING OUT OF THE BALLOON. THE BALLOON CATHETER WAS WITHDRAWN AND A PINHOLE WAS DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14579622 ↗MalfunctionJun 2, 2022Material Puncture/Hole; Material Puncture/Hole
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR PRE-DILATATION OF A MODERATELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS SFA. DURING INFLATION UP TO 6 ATM, IT WAS NOTED THAT CONTRAST MEDIUM WAS LEAKING OUT OF THE BALLOON. THE BALLOON CATHETER WAS WITHDRAWN AND A PINHOLE WAS DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14579581 ↗
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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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