XTRA BOWL SET X/125Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033178110020), received between Nov 8, 2017 and May 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992329 ↗
• MalfunctionNov 8, 2017Sediment, Precipitate Or Deposit In Device Or Device Ingredient; Sediment, Precipitate Or Deposit In Device Or Device Ingredient

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT SMALL (APPROXIMATELY 2-3 MM IN SIZE) BLACK PARTICLES WERE NOTED WITHIN THE SALVAGED BLOOD THAT WAS PROCESSED WITH THE XTRA AUTOTRANSFUSION SYSTEM AND SENT TO THE RE-INFUSION BAG. RE-INFUSION WAS NOT PERFORMED AND THE WHOLE PROCEDURE SET WAS PUT ASIDE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7008919 ↗