CARDINAL HEALTH SAN30AFMMFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488490779), received between Sep 2, 2022 and Sep 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionSep 2, 2022Material Separation; Material Separation

  CUSTOMER REPORTED AN ABUNDANCE OF LINT FROM THE COTTON TOWEL, PWTB04-STM, DURING AN ANGIOPLASTY IN THE CATHETERIZATION LABORATORY USING A CARDINAL HEALTH FEMORAL ANGIOGRAPHY PACK , SAN30AFMMG. THE DOCTOR FREQUENTLY RINSES AND DRIES HIS GLOVED HANDS WITH THE TOWEL DURING PROCEDURE AND HE SOMETIMES PLACES THE TOWEL ON THE BOTTOM OF THE GUIDEWIRE. THE PATIENT SUFFERED NO COMPLICATION DURING PROCEDURE NOR AFTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351804 ↗