CARDINAL HEALTH SAN21HCNS8Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195594412524), received between Aug 18, 2022 and Aug 18, 2022 — classified as 1 malfunction.

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

• MalfunctionAug 18, 2022Material Separation; Material Separation

  CUSTOMER REPORTED THAT LINT FROM THE COTTON TOWEL, PWTB04-STM, WAS FOUND ON THE GAUZE SPONGE FROM THE HEART CATHETERIZATION PACK, SAN21HCNSC. PRODUCT ISSUE WAS FOUND DURING PROCEDURE. THERE WAS AN APPROXIMATE DELAY OF TEN MINUTES. THE LINT WAS FOUND ON THE EQUIPMENT, WIRE, BALLOON AND IVUS (INTRAVASCULAR ULTRASOUND) SHAFT, AND WAS DISPOSED. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254511 ↗