XTRA PROCEDURE SET BX/225Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033178110808), received between Jul 6, 2016 and Jul 4, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 4, 2024Fracture; Fracture

  SORIN GROUP ITALY RECEIVED A REPORT THAT THE UPPER PORTION OF AN XTRA BOWL COMING SEPARATED FROM THE BOTTOM PORTION THAT SITS IN THE CENTRIFUGE WELL AND AS A CONSEQUENCE THERE WAS A SIGNIFICANT AMOUNT OF FLUID LOSS. BLOOD LEAKED OUT THE BOWL AND CENTRIFUGE AND THE USER WAS CONTAMINATED. THE ISSUE OCCURRED DURING PROCEDURE. THE BOWL PLATE WAS LEFT IN THE CENTRIFUGE WELL AND THE CUSTOMER HAD TO USE A SCREWDRIVER TO PRY THE DISPOSABLE BASE FROM THE CENTRIFUGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674951 ↗
• MalfunctionApr 5, 2017Disconnection; Disconnection

  SORIN GROUP (B)(6) RECEIVED A REPORT THAT THE BLUE TUBING FROM THE XTRA PROCEDURE SET DISCONNECTED FROM THE RESERVOIR DURING A CASE AND BLOOD SPILLED ON FLOOR AND DOCTOR. THE TUBING WAS RECONNECTED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT INJURY, AND NO INJURY WAS REPORTED FOR THE DOCTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6459594 ↗
• Jul 6, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  SORIN GROUP (B)(4) RECEIVED A USER MEDWATCH REPORT (MW5062325) ON JUNE 13, 2016 STATING THAT THE XTRA BOWL FOR THE XTRA AUTOTRANSFUSION SYSTEM DID NOT EMPTY PROPERLY DURING A PROCEDURE. THE BOWL WOULD PARTIALLY EMPTY AND THEN STOP. THE BOWL WAS CHANGED TO ANOTHER FROM THE SAME LOT AND THE SAME ISSUE OCCURRED. A THIRD DIFFERENTLY SIZED BOWL FROM A DIFFERENT LOT WAS SET UP AND WORKED PROPERLY. THE CUSTOMER REPORTED THAT 2000ML OF SALVAGED BLOOD WAS DISCARDED DUE TO THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5774159 ↗