Passeo-18 4/80/130Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640119559162), received between May 13, 2021 and Aug 23, 2024 — classified as 3 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
- Material Puncture/Hole1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2024Failure to Advance; Failure to Advance
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION OF A MILDLY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID SFA, BUT THE DEVICE COULD NOT PASS THE LESION. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20053979 ↗MalfunctionJun 10, 2021Material Puncture/Hole; Material Puncture/Hole
A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT. THE BALLOON WAS PLACED PROPERLY IN THE LESION. IT WAS ATTEMPTED TO INFLATE THE BALLOON AS USUAL. GOING UP TO NP WAS POSSIBLE WITHOUT PROBLEMS BUT WHEN ARRIVING AT 5 ATM, THE PRESSURE OF THE BALLOON WOULD SLOWLY TURN DOWN. TO KEEP THE BALLOON INFLATED AT 5 ATM MORE PRESSURE NEEDED TO BE APPLIED. A NEW BALLOON WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11980305 ↗MalfunctionMay 13, 2021Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR THE TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS SFA. DURING INFLATION UP TO 14 ATM THE BALLOON BUST. THE INTERVENTION WAS COMPLETED WITH ANOTHER PASSEO-18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11816515 ↗
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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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