Passeo-18 3/170/130Recalls & 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 07640119559247), received between Mar 14, 2023 and Apr 17, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Failure to Advance1
- Fluid/Blood Leak1
- Inflation Problem1
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.
MalfunctionApr 17, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A PREDILATED MILDLY CALCIFIED LESION IN A MILDLY TORTUOUS SECTION OF THE DISTAL POSTERIOR TIBIAL ARTERY. DURING THE ADVANCEMENT OF THE PASSEO-18, THE BALLOON WAS INTRODUCED AND INFLATED, BUT IT FAILED TO MAINTAIN PRESSURE. THE DECISION WAS MADE TO REMOVE THE BALLOON, AND UPON TESTING IT OUTSIDE THE PATIENT, A LEAK WAS IDENTIFIED, CONFIRMING THAT THE BALLOON WAS NOT INFLATING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21859503 ↗MalfunctionMar 14, 2023Failure to Advance; Failure to Advance
THE PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE PRE-DILATED MODERATELY CALCIFIED LESION IN THE OSTIAL FEMORAL ARTERY COULD NOT BE CROSSED WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16541724 ↗
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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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