CARDINAL HEALTH SCV43OHOFDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439906776), received between Apr 23, 2021 and Apr 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2021Material Separation; Material Separation

  CUSTOMER REPORTED THAT BLUE TOWELS PWTB04-STM FROM THE PEDIATRIC OPEN HEART KIT SCV43OHOFD WERE FADED AND SHEDDING QUITE A LOT OF LINT. NO FURTHER INFORMATION OR DEMOGRAPHICS WERE PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720642 ↗