CARDINAL HEALTH SAN21CLARDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439838305), received between Mar 29, 2021 and Apr 2, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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 2, 2021Material Separation; Material Separation

  CUSTOMER REPORTED LINTING OF THE BLUE, NON-XRAY COTTON TOWELS PWTB04-STM FROM THE CATH LAB PACK SAN21CLARD FOUND ON WIRE DURING A CORONARY INTERVENTION. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611293 ↗
• MalfunctionMar 29, 2021Material Separation; Material Separation

  CUSTOMER REPORTED LINTING OF THE BLUE, NON-XRAY COTTON TOWELS PWTB04-STM FROM THE CATH LAB PACK SAN21CLARD FOUND ON WIRE DURING A CORONARY INTERVENTION. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585551 ↗