Passeo-18 2.5/170/130Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640119559230), received between Jan 20, 2021 and Jun 2, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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.
Most reported problems
Device problems
- Failure to Advance1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2022Material Puncture/Hole; Material Puncture/Hole
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF 200MM LONG LESION IN AN ARTERY OF THE LOWER EXTREMITY. DURING INFLATION THE BALLOON COULD NOT BE EXPANDED AS EXPECTED. THE DEVICE WAS WITHDRAWN, AND A PINHOLE WAS DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14579514 ↗MalfunctionJan 20, 2021Failure to Advance; Failure to Advance
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR THE TREATMENT. THE SEVERELY CALCIFIED LESION COULD NOT BE CROSSED WITH THE DEVICE. NOTE THIS DEVICE HAS TWO PMA/510K NUMBERS. THE ADDITIONAL ONE IS K151744 WHICH CONTAINS A LINE EXTENSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11200893 ↗
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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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