CARDINAL HEALTH SAN34ANAVJRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439440225), received between Sep 25, 2019 and Sep 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.

• MalfunctionSep 25, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT LINT FROM THE BLUE OR TOWELS PWTB04-STM, FROM THE ANGIOGRAPHY KIT SAN34ANAVJ, WAS FOUND ON THE ENDOVASCULAR WIRE AND WITHIN THE PACK DURING AN ANGIOGRAPHY. THERE WAS AN INSIGNIFICANT DELAY TO OPEN A SEPARATE TOWEL PACK. THERE WAS NO INJURY TO THE PATIENT AS THE PATIENT WAS NOT UNDER ANESTHESIA. MDR BEING REPORTED BASED ON POTENTIAL RISK TO THE PATIENT. NO PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9120753 ↗