CARDINAL HEALTH SAN44PMHDDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488480220), received between May 11, 2020 and May 11, 2020 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2020Contamination /Decontamination Problem

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THE BLUE TOWELS IN THE PACKS ARE ALLEGEDLY LEAVING BEHIND BLUE LINT. (PACEMAKER IMPLANT.) PER THE CUSTOMER THERE WAS NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10042872 ↗