Passeo-18 2/120/150Recalls & 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 07640130414686), received between Dec 13, 2019 and Oct 25, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Difficult to Remove1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2023Fluid/Blood Leak; Fluid/Blood Leak
A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF AN ARTERIOVENOUS FISTULA. AFTER INSERTION, DURING INFLATION OF THE DEVICE, IT WAS NOTICED THAT THE BALLOON WAS LEAKING. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE. THE PATIENT WAS STABLE AND DISCHARGED HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18004694 ↗MalfunctionNov 30, 2022Difficult to Remove; Difficult to Remove
A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS OSTIAL RENAL ARTERY. AFTER DILATATION OF THE PASSEO-18 BALLOON CATHETER, THE BALLOON WAS BLOCKED AND GOT STUCK TOGETHER WITH THE GUIDEWIRE. THUS, BOTH DEVICES HAD TO BE WITHDRAWN AT THE SAME TIME, BUT THE ACCESS GOT LOST AND THEREFORE, THE OPERATION TIME WAS EXTENDED FOR 60 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15887651 ↗MalfunctionJan 27, 2020Leak/Splash; Leak/Splash
THE PASSEO-18 BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED MORE THAN 2 ATM. AFTER REMOVAL, A HOLE WAS DETECTED AT THE END OF THE BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9632163 ↗MalfunctionDec 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
A PASSEO-18 BALLOON CATHETER WAS CHOSEN TO DILATE A CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS PROXIMAL ATA. DURING INFLATION A LEAKAGE OF THE CONTRAST MEDIUM WAS NOTICED AND THE BALLOON WAS CONFIRMED TO BE BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9469576 ↗
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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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