CARDINAL HEALTH SANHFCCFTBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439231755), received between Mar 2, 2019 and Mar 2, 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.

• MalfunctionMar 2, 2019Failure to Advance; Contamination /Decontamination Problem

  THE CUSTOMER REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE DOCTOR COULD NOT ADVANCE ANY BALLOONS OR STENTS OVER THE ANGIOPLASTY WIRE AFTER MULTIPLE ATTEMPTS. THE TECH RECOMMENDED CHANGING WIRES. WHEN THE WIRE WAS REMOVED, THE TEAM SAW A LARGE PIECE OF LINT ON THE ANGIOPLASTY WIRE. THE SURMISED THAT IT CAME FROM THE FEMORAL DRAPE 29570NA FROM THE CARDIAC CATHETER KIT/SANHFCCFTB . THEY ALSO FOUND A LARGE AMOUNT OF LINT ON THEIR GLOVES AND IN THE STERILE HEPARIN SALINE FLUSH BOWL. THEY REPORTED THERE WAS NO PATIENT INJURY. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN ASKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8384777 ↗