CARDINAL HEALTH SAN21ADARBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488884516), received between May 28, 2019 and May 28, 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.

• MalfunctionMay 28, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT THE BLUE OR TOWELS PWTB04-STM IN THE CATHETERIZATION PACK SAN21ADARB LEFT A LINTY RESIDUE ON THE SCRUB TECH¿S GLOVES AND ON A WIRE. THE PROCEDURE WAS A CARDIAC CATHETERIZATION WITH PERCUTANEOUS CORONARY INTERVENTION. NO PATIENT DEMOGRAPHICS WERE PROVIDED, NO DELAY IN PROCEDURE AND NO INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8648436 ↗