CARDINAL HEALTH SAN45VAPECRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439908220), received between Mar 3, 2021 and Mar 3, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (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.

• MalfunctionMar 3, 2021Material Frayed; Material Frayed

  CUSTOMER REPORTED AN ABUNDANCE OF LINT OF THE BLUE COTTON OR TOWELS, PWTB04-STM FROM THE VASCULAR ACCESS PACK, SAN45VAPEC. THE ISSUE WAS FOUND BEFORE THE PROCEDURE. TOWELS WERE REMOVED AND NO INJURY WAS REPORTED TO PATIENT. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11406461 ↗