XTRA BOWL SET X/175Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033178110037), received between Feb 8, 2018 and Feb 8, 2018 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2018Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT A LEAK FROM THE BOWL OF AN XTRA AUTOTRANSFUSION SET OCCURRED DURING BLOOD COLLECTION FROM SURGICAL FIELD. THE SURGICAL PROCEDURE WAS CONDUCTED DUE TO POSTPARTUM HEMORRHAGE. THE BLOOD COLLECTED COULD NOT BE PROCESSED AND THE PATIENT HAD TO BE GIVEN A BANK BLOOD TRANSFUSION. THE CUSTOMER LATER REPORTED THAT THE SURGICAL PROCEDURE ENDED WITH A HYSTERECTOMY AND SEPSIS FOR THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Sepsis

  MAUDE report 7250637 ↗