CARDINAL HEALTH SAN44DVUTARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439390391), received between May 29, 2020 and May 29, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Disintegration” (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 29, 2020Material Disintegration

  CUSTOMER REPORTED THAT THE BLUE, STERILE, COTTON OR TOWELS PWTB04-STM, FROM THE IR NEURO PACK SAN44DVUTA/LOT 426625 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 Known Impact Or Consequence To Patient

  MAUDE report 10102845 ↗