CARDINAL HEALTH SAN44CAUTARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439390377), received between May 27, 2020 and May 27, 2020 — 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.

• MalfunctionMay 27, 2020Contamination /Decontamination Problem

  CUSTOMER REPORTED THAT THE BLUE, STERILE, COTTON OR TOWELS PWTB04-STM FROM THE CUSTOM ANGIO PACK SAN44CAUTA ARE SHEDDING FIBERS ONTO VARIOUS WIRES AND CATHETERS DURING A LEFT VERTEBRAL ARTERY ANGIOPLASTY AND STENTING. THE TOWELS WERE USED FOR FLUID ABSORPTION OUTSIDE THE DRAPE. THERE WAS A 30- MINUTE DELAY, WITH NO INJURY OR ADVERSE EFFECT TO THE PATIENT. NO PATIENT DEMOGRAPHICS WERE PROVIDED. CARDINAL HEALTH IS PROACTIVELY FILING A REPORT FOR MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10094208 ↗