CARDINAL HEALTH SAN13CLMGDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488811413), received between Mar 1, 2019 and Mar 1, 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.

• MalfunctionMar 1, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT DURING A SETUP FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT, LINT FIBERS FROM THE BLUE OR TOWELS PWTB04-STM FROM THE CATHETER LAB TRAY KIT/ SAN13CLMGD WERE FOUND IN BOTH THEIR WHITE AND BLUE BOWLS THAT WERE FILLED WITH NORMAL SALINE AND HEPARINIZED SOLUTION. THERE WAS NO PATIENT INJURY OR DELAY AND IT WAS REPORTED THAT THE PATIENT WAS DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8383682 ↗