CARDINAL HEALTH SAN46CCEDDRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888439629866), received between Sep 10, 2020 and Nov 16, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2022Material Separation; Material Separation

  CUSTOMER REPORTED THAT DURING A CARDIAC CATHETERIZATION PROCEDURE, THE CLOTH TOWELS PWTB04-STM FROM THE CARDIAC CATHETERIZATION PACK SAN46CCEDD WERE LINTING. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER UPON REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15810473 ↗
• MalfunctionSep 10, 2020Particulates

  THE CUSTOMER REPORTED SURGEON WAS DOING A PERIPHERAL PROCEDURE AND AS THEY WERE RUNNING THE CATHETER, THEY STARTED TO DEVELOP SMALL EMBOLIZED FLUFF BALLS THAT COULD POSSIBLY GO INTO THE PATIENT AND CAUSE A SERIOUS ISSUE. THERE WAS NO INJURY OR ADVERSE EVENT TO THE PATIENT THAT REQUIRED ADDITIONAL MEDICAL TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10518876 ↗
• MalfunctionSep 10, 2020Material Fragmentation

  THE CUSTOMER REPORTED SURGEON WAS DOING A PERIPHERAL PROCEDURE AND AS THEY WERE RUNNING THE CATHETER, THEY STARTED TO DEVELOP SMALL EMBOLIZED FLUFF BALLS THAT COULD POSSIBLY GO INTO THE PATIENT AND CAUSE A SERIOUS ISSUE. THERE WAS NO INJURY OR ADVERSE EVENT TO THE (B)(6) YEAR-OLD MALE PATIENT THAT REQUIRED ADDITIONAL MEDICAL TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10518871 ↗