CARDINAL HEALTH SAN5CCSGSDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439432428), received between Jul 12, 2019 and Jul 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.

• MalfunctionJul 12, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED LINTING OF THE BLUE NON-X-RAY TOWELS 101625 FROM THE CATHETERIZATION SPECIALS PACK/ (B)(4). THE PROCEDURE PERFORMED WAS AN INVASIVE CARDIAC ANGIOGRAM WHERE THERE WAS A DELAY MID PROCEDURE TO EVALUATE LINT SEEN ON INSTRUMENTS AND TO MAKE SURE ALL INSTRUMENTS WERE CLEAN, PRIOR TO ENTERING THE PATIENT¿S BODY. THERE WAS NO PATIENT INJURY. NO PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785528 ↗