CARDINAL HEALTH SAN35EPSTIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439200058), received between Jan 25, 2019 and Jan 25, 2019 — 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.

• MalfunctionJan 25, 2019Contamination /Decontamination Problem

  THE CUSTOMER STATED THE TOWELS PWTB04-STM FROM THE ELECTRO PHYSIOLOGY PACK CATALOG NUMBER SAN35EPSTI WERE LINTING. THE STAFF PICKED UP THE GUIDEWIRE OFF THE OR TOWEL AND INSERTED IT INTO THE PATIENT AND WHEN THEY PULLED IT OUT THEY SAW LINT ON THE GUIDEWIRE. THEY PUT IT ASIDE AND PICKED A NEW ONE TO FINISH THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. NO PATIENT IDENTIFIERS WERE PROVIDED WHEN ASKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8279400 ↗