CARDINAL HEALTH SAN51CCKKGRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887488734729), received between Feb 16, 2021 and Feb 16, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2021Material Separation; Material Separation

  SURGEON HAD TO REOPEN TOWEL SUPPLIES MID CARDIAC CATHETERIZATION SINCE HE OBSERVED A VERY HIGH AMOUNT OF LINT FROM THE COTTON OPERATING ROOM TOWELS PWTB04-STM IN THE CARDIAC CATHETERIZATION PACK SAN51CCKKG ON HIS GLOVES AND WIRES. NO INJURY WAS REPORTED. NO PATIENT DEMOGRAPHICS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335622 ↗
• MalfunctionFeb 16, 2021Material Separation; Material Separation

  SURGEON HAD TO REOPEN TOWEL SUPPLIES MID CARDIAC CATHETERIZATION SINCE HE OBSERVED A VERY HIGH AMOUNT OF LINT FROM THE COTTON OPERATING ROOM TOWELS PWTB04-STM IN THE CARDIAC CATHETERIZATION PACK SAN51CCKKG ON HIS GLOVES AND WIRES. NO INJURY WAS REPORTED. NO PATIENT DEMOGRAPHICS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335598 ↗
• MalfunctionFeb 16, 2021Material Separation; Material Separation

  SURGEON HAD TO REOPEN TOWEL SUPPLIES MID CARDIAC CATHETERIZATION SINCE HE OBSERVED A VERY HIGH AMOUNT OF LINT FROM THE COTTON OPERATING ROOM TOWELS PWTB04-STM IN THE CARDIAC CATHETERIZATION PACK SAN51CCKKG ON HIS GLOVES AND WIRES. NO INJURY WAS REPORTED. NO PATIENT DEMOGRAPHICS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335577 ↗
• MalfunctionFeb 16, 2021Contamination /Decontamination Problem

  SURGEON HAD TO REOPEN TOWEL SUPPLIES MID CARDIAC CATHETERIZATION SINCE HE OBSERVED A VERY HIGH AMOUNT OF LINT FROM THE COTTON OR TOWELS PWTB04-STM IN THE CARDIAC CATHETERIZATION PACK SAN51CCKKG ON HIS GLOVES AND WIRES. NO INJURY WAS REPORTED. NO PATIENT DEMOGRAPHICS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11335471 ↗