CARDINAL HEALTH PC24OHNOJRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439181975), received between Jan 7, 2020 and May 4, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 4, 2021Material Separation; Material Separation

  CUSTOMER REPORTED EXCESSIVE LINTING OF THE BLUE OR TOWELS PWTB04-STM FROM THE OPEN HEART SETUP KIT PC24OHNOJ. THE TOWELS WERE IMMEDIATELY REMOVED AND REPLACED AFTER THE LINTING WAS NOTICED. NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED WHEN ASKED. REPORT BEING FILED FOR POTENTIAL RISK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773250 ↗
• MalfunctionJan 7, 2020Device Contamination with Chemical or Other Material

  THE CUSTOMER STATED THAT THE BLUE OPERATING ROOM (OR) TOWELS PWTB04-STM FROM THE OPEN HEART KIT/ PC24OHNOJ LEFT LINT ON THE PATIENT DURING AN OPEN HEART PROCEDURE. NO INJURY WAS REPORTED. NO PATIENT DEMOGRAPHICS OR EVENT DATE WERE PROVIDED AFTER MULTIPLE ATTEMPTS TO RETRIEVE FROM CUSTOMER. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS PROACTIVELY FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9560619 ↗