Passeo-18 4/40/90Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-18 (54)
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 07640119558721), received between May 18, 2022 and Apr 23, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
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 23, 2025Material Rupture; Material Rupture
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (30 PERCENT STENOSIS DEGREE) IN THE DISTAL POPLITEAL ARTERY. DURING INFLATION THE BALLOON RUPTURED AT 5 ATM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21892286 ↗MalfunctionMay 18, 2022Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS DISTAL POPLITEAL ARTERY. IT WAS NOT POSSIBLE TO INFLATE THE PASSEO-18 BALLOON CATHETER DUE TO A BALLOON RUPTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14431579 ↗
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- Coyote™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page