Passeo-14 2.5/70/150Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-14 (13)
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 07640130433632), received between Jan 16, 2025 and Nov 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Fluid/Blood Leak1
- 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.
MalfunctionNov 21, 2025Difficult to Remove; Difficult to Remove
THE PASSEO-14 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR DILATATION OF A MILDLY CALCIFIED LESION IN THE MID ANTERIOR TIBIAL ARTERY (ATA). DIFFICULTIES OCCURRED WHILE PULLING OUT THE BALLOON CATHETER FROM THE SHEATH AFTER DEFLATION. AFTER PULLING OUT THE DEVICE, IT WAS DETECTED THAT THE STIFFENING WIRE CAME OUT FROM THE DISTAL SHAFT NEAR THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23616461 ↗MalfunctionJan 16, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE PASSEO-14 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR DILATATION OF A MILDLY CALCIFIED LESION IN THE MID ANTERIOR TIBIAL ARTERY (ATA). THE BALLOON WAS POSITIONED AT PROXIMAL PART OF THE ATA LESION AND INFLATED UP TO RATED BURST PRESSURE TWICE. IT LEAKED DURING THIRD INFLATION AT 10 ATM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21170293 ↗
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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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