CARDINAL HEALTH SAN44SRUTBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439526622), received between May 29, 2020 and Apr 9, 2021 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2021Material Frayed; Material Frayed

  CUSTOMER REPORTED THE SURGICAL TOWEL PWTB04-STM, INCLUDED IN THIS KIT SAN44SRUTB ARE LEAVES FRAGMENTS ON THE WIRES AND CATHETERS DURING ARTERIOGRAM PROCEDURE. NO INJURY OR ADVERSE EFFECT REPORTED. NO PATIENT DEMOGRAPHICS WERE PROVIDED UPON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11639507 ↗
• MalfunctionMay 29, 2020Contamination /Decontamination Problem

  CUSTOMER REPORTED THAT THE BLUE ,COTTON OR TOWELS PWTB04-STM, FROM THE IR PACK SAN44SRUTB ARE SHEDDING FIBERS ONTO VARIOUS WIRES AND CATHETERS DURING AN INTRACRANIAL EMBOLIZATION. THE TOWELS WERE USED FOR FLUID ABSORPTION OUTSIDE THE DRAPE. THERE WAS NO INJURY OR DELAY. NO PATIENT DEMOGRAPHICS WERE PROVIDED UPON REQUEST. CARDINAL HEALTH IS FILING A REPORT FOR MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10103420 ↗