CARDINAL HEALTH SAN3BCLK11Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195594459376), received between Nov 17, 2022 and Nov 17, 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.

• MalfunctionNov 17, 2022Material Separation; Material Separation

  CUSTOMER REPORTED AN ABUNDANCE OF LINT FROM THE BLUE COTTON OR TOWELS PWTB04-STM, FROM THE SAN3BCLK11 CATH LAB TRAY. LINT WAS FOUND IN THE CORONARY ARTERIES AND REMOVED SUCCESSFULLY WITH NO INJURY OR ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15818159 ↗