Oscar 2.5/20-180/127Recalls & reported problems
Biotronik AG · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130455801), received between Jan 4, 2023 and Apr 22, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Vascular Dissection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2025Fracture; Fracture
AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT OF THE POSTERIOR TIBIAL ARTERY. THE OSCAR-PTA BALLOON METAL CATHETER HAS BROKEN NEAR THE HUB WHILE PUSHING. NO INJURY WAS REPORTED. THE PATIENT WAS DISCHARGED HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21884157 ↗InjuryMar 30, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT. DURING TREATMENT A DISSECTION OF POSTERIOR TIBIAL ARTERY HAD OCCURRED.
Patient problems: Vascular Dissection
MAUDE report 16645664 ↗MalfunctionJan 4, 2023Fracture; Fracture
AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT. PUSHING PTA BALLOON FROM METAL HYPOTUBE THROUGH PLANTAR ARTERY, TUBE BROKE IN TWO SECTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16096181 ↗
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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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