CARDINAL HEALTH SAN44CLHDFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887488933528), received between May 11, 2020 and May 11, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2020Material Fragmentation

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THE BLUE TOWELS IN THE PACKS ARE ALLEGEDLY LEAVING BEHIND BLUE LINT. THE CONCERN IS THAT THE LINT HAS BEEN FOUND ON THE WIRES THAT ARE INSERTED INTO THE ARTERIAL SYSTEM. ((DEFIBRILLATOR IMPLANT) PER THE CUSTOMER THERE WAS NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10042721 ↗
• MalfunctionMay 11, 2020Contamination /Decontamination Problem

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THE BLUE TOWELS IN THE PACKS ARE ALLEGEDLY LEAVING BEHIND BLUE LINT. THE CONCERN IS THAT THE LINT HAS BEEN FOUND ON THE WIRES THAT ARE INSERTED INTO THE ARTERIAL SYSTEM. (LEFT CATHETERIZATION) PER THE CUSTOMER THERE WAS NO INJURY TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10042596 ↗