CARDINAL HEALTH SAN44IRUTARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439390407), received between May 15, 2020 and May 29, 2020 — classified as 2 malfunctions.

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

• MalfunctionMay 29, 2020Therapeutic or Diagnostic Output Failure

  CUSTOMER REPORTED THAT THE BLUE, STERILE, COTTON OR TOWELS PWTB04-STM, FROM THE IR NEURO PACK SAN44IRUTA/LOT 375598 ARE SHEDDING FIBERS ONTO VARIOUS WIRES AND CATHETERS DURING A INTRACRANIAL EMBOLIZATION. THE TOWELS WERE USED FOR FLUID ABSORPTION OUTSIDE THE DRAPE. THERE WAS NO INJURY OR DELAY. NO PATIENT DEMOGRAPHICS WERE PROVIDED AFTER ATTEMPTS. CARDINAL HEALTH IS PROACTIVELY FILING A REPORT FOR MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10102513 ↗
• MalfunctionMay 15, 2020Material Fragmentation

  CUSTOMER REPORTED THAT THE BLUE, STERILE, COTTON OR TOWELS PWTB04-STM, FROM THE IR NEURO PACK SAN44IRUTA ARE SHEDDING FIBERS ONTO VARIOUS WIRES AND CATHETERS DURING A INTRACRANIAL EMBOLIZATION. THE TOWELS WERE USED FOR FLUID ABSORPTION OUTSIDE THE DRAPE. THERE WAS NO INJURY OR DELAY. CARDINAL HEALTH IS FILING A REPORT FOR MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063105 ↗