Oscar 6.0/20-180/128Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130455757), received between Aug 8, 2023 and Feb 27, 2024 — classified as 3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2024Entrapment of Device; Difficult to Remove; Material Rupture; Entrapment of Device; Difficult to Remove; Material Rupture

  AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS SFA. DURING A CROSSOVER PROCEDURE, THE OSCAR SUPPORT CATHETER WITH THE DILATATOR WAS USED BUT COULDNT CROSS THE LESION WITH THE DILATATOR. SO, IT WAS DECIDED TO CHANGE TO THE 6MM OSCAR PTA BALLOON. IT WAS MANAGED TO CROSS THE STENOSIS AND A DILATATION UP TO 6BAR WAS DONE. THE PTA BALLOON IMMEDIATELY RUPTURED. AFTERWARDS IT WAS NOT POSSIBLE TO PULL THE PTA BALLOON OUT OF THE SUPPORT CATHETER. IT GOT STUCK. SO, THE WHOLE OSCAR SYSTEM WAS REMOVED. NOTHING REMAINED IN PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OTHER PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789502 ↗
• MalfunctionAug 10, 2023Fracture; Fracture

  AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT. EVENT OCCURRED WHILE USING OSCAR ATTEMPTING TO CROSS A LESION (100 PERCENT STENOSIS DEGREE) IN THE SFA. A CONTRALATERAL APPROACH WAS USED, AND WHILE ADVANCING THE OSCAR SYSTEM THE PROXIMAL SHAFT OF DILATOR FRACTURED. SYSTEM WAS THEN REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498939 ↗
• MalfunctionAug 8, 2023Fracture; Fracture

  AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS DISTAL RCA. THE OSCAR WAS USED CROSS OVER FROM THE LEFT TO THE RIGHT DISTAL SFA AND INSERTED WITH THE DILATATOR IN POSITION 0. ONLY THE DILATOR COULD BE PUSHED FROM THE MIDDLE SFA FURTHER DOWN BUT NOT THE SUPPORT CATHETER, SO IT WAS DECIDED TO EXCHANGE THE DILATATOR WITH THE 6MM PTA BALLOON. DURING PULLING THE DILATATOR OUT, MASSIVE FRICTION WAS NOTICED. EVERYTHING WAS STRAIGHT, NO KINK OF THE WIRE WAS NOTICED. DURING PULLING THE DILATATOR OUT, THE SHAFT BROKE WHERE THE METAL SHAFT ENDS AND OVERLAPS TO THE PLASTIC SHAFT. IT WAS POSSIBLE TO TAKE THE DILATATOR FULLY OUT. ANOTHER BALLOON WAS USED. THE INTERVENTION WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483370 ↗