Passeo-14 2/140/150Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-14 (13)
Data updated Oct 16, 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 07640130433748), received between Jun 8, 2021 and Feb 28, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (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 16, 2026.
Most reported problems
Device problems
- Inflation Problem1
- Material Rupture1
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.
MalfunctionFeb 28, 2023Material Rupture; Material Rupture
A PASSEO-14 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. WHEN INFLATING THE BALLOON UP TO 4.5 BAR, THE BALLOON CRACKED, ALTHOUGH NO CALCIFICATION WAS SEEN IN THE VESSEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16451912 ↗MalfunctionJun 8, 2021Inflation Problem; Inflation Problem
THE PASSEO-14 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS LEFT SUBCLAVIAN ARTERY. AFTER LESION CROSSING IT WAS NOT POSSIBLE TO INFLATE THE PASSEO-14 BALLOON CATHETER. THE DEVICE WAS REMOVED AND ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11957218 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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