Oscar PTA 3.0/20-180/127Recalls & reported problems
Biotronik AG · Class 2
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 07640130455689), received between Jan 4, 2023 and Feb 8, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation2
- Fracture1
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 8, 2024Material Deformation; Material Deformation
IT WAS INTENDED TO TREAT A MODERATELY CALCIFIED CTO LESION IN A MODERATELY TORTUOUS SEGMENT OF THE ANTERIOR TIBIAL ARTERY. AN OSCAR PTA BALLOON WAS INTRODUCED AND SUCCESSFULLY INFLATED. AFTER INFLATION, THE GUIDEWIRE GOT DAMAGED AND SHOWED A WRINKLING AT THE DISTAL END, FOLLOWING IT WAS NOT POSSIBLE TO REMOVE THE GUIDEWIRE. BOTH, GUIDE WIRE AND OSCAR PTA BALLOON WERE REMOVED, AND A DAMAGE TO THE HYDROPHILIC COATING OF THE GUIDE WIRE WAS CONFIRMED. A NEW WIRE WAS INTRODUCED, AND THE BALLOON WAS POSITIONED IN THE TARGET LESION. A SECOND INFLATION WAS NOT POSSIBLE AS THE OSCAR PTA BALLOON LEAKED (REPORTED UNDER 1028232-2024-00128). A SECOND OSCAR PTA BALLOON (COMPLAINT DEVICE) WAS INTRODUCED TOGETHER WITH THE NEW GUIDE WIRE. DURING MANIPULATION, THE SECOND GUIDE WIRE GOT DAMAGED AS WELL, THE HYDROPHILIC COATING GOT PEELED OFF. BOTH, THE GUIDE WIRE AND THE SECOND OSCAR PTA BALLOON WERE WITHDRAWN, AND THE INTERVENTION WAS FINALIZED USING A STANDARD PTA BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18669194 ↗MalfunctionJan 4, 2023Fracture; Material Deformation; Fracture; Material Deformation
AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT. THE BALLOON HUB WAS KINKED AND BROKE IN A DIFFUSE CTO LESION. ANOTHER 3.0 BALLOON WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16096371 ↗
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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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