CARDINAL HEALTH SANHDLHSNBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488707204), received between Dec 12, 2019 and Dec 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionDec 12, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT DURING A LEFT HEART CATHETERIZATION WITH PERCUTANEOUS CORONARY INTERVENTION, BLUE LINT FROM THE BLUE OR TOWELS PWTB04-STM FROM THE LEFT HEART CATHETERIZATION PACK/ SANHDLHSNB WAS FOUND IN THE IRRIGATION BOWL AFTER THE DOCTOR WIPED HIS HANDS. THE TOWELS WERE USED ON TOP OF THE DRAPE AND TO WIPE THE SURGEON'S HANDS. THE LINT WAS FOUND PRIOR TO REACHING THE PATIENT. PER THE CUSTOMER, THERE WAS NO INJURY TO THE PATIENT. NO PATIENT DEMOGRAPHICS WERE PROVIDED. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS PROACTIVELY FILING AN MDR REPORT FOR POTENTIAL RISK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9457592 ↗