CARDINAL HEALTH SAN6BCCOMFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488635866), received between Jun 6, 2019 and Jun 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• MalfunctionJun 6, 2019Material Fragmentation

  THE CUSTOMER REPORTED THAT THE OR TOWELS (B)(4) FROM THE CARDIAC CATHETERIZATION PACK/ (B)(4) WERE SHEDDING FIBERS ONTO THE WIRES BEFORE ENTERING THE PATIENT¿S BODY AND IN THE RINSE BOWL. THE PROCEDURE PERFORMED WAS A CARDIAC LEFT HEART CATHETERIZATION WITH POSSIBILITY OF STENTING. THERE WAS NO INJURY OR DELAY. NO PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674345 ↗