CARDINAL HEALTH SAN69CLKSDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887488754642), received between Aug 23, 2019 and Aug 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 23, 2019Device Contamination with Chemical or Other Material

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, ALLEGEDLY, WHEN TRYING TO REMOVE THE CLOT, IT APPEARED SOMETHING WAS GETTING STUCK ON THE CATHETER. REPORTEDLY THE CLOT WAS ASPIRATED OUT AND UPON INSPECTION IT SEEMINGLY APPEARED TO BE A PIECE OF BLUE LINT FROM ONE OF THE TOWELS COMMONLY USED IN THE PROCEDURE, WAS PART OF THE CLOT. THE ENTIRE CLOT WAS REMOVED, THERE WAS NO OTHER CLOT VISIBLE IN THE PATIENT ARTERY. PATIENT HAD NO CHEST PAIN AND ST ELEVATION RESOLVE. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8926923 ↗