CARDINAL HEALTH SANDHCCCF2Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888439306071), received between Apr 17, 2019 and Apr 17, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED LINTING OF THE OR TOWELS PWTB03-STMA FROM THE CARDIAC CATHETER TRAY KIT SANDHCCCF2 DURING A CARDIAC CATHETERIZATION. THE PROCEDURE PROGRESSED CAUTIOUSLY DUE TO THE NEED TO OBSERVE FOR LINT ON WIRES, BALLOONS, STENTS AND GLOVES. STAFF AND DOCTOR NEEDED TO CHANGE GLOVES DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. NO PATIENT DEMOGRAPHICS WERE PROVIDED. THE EVENT DATE WAS REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8525621 ↗
• MalfunctionApr 17, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED LINTING OF THE OPERATING ROOM TOWELS PWTB03-STMA FROM THE CARDIAC CATHETER TRAY KIT SANDHCCCF2 DURING A CARDIAC CATHETERIZATION. THE PROCEDURE PROGRESSED CAUTIOUSLY DUE TO THE NEED TO OBSERVE FOR LINT ON WIRES, BALLOONS, STENTS AND GLOVES. STAFF AND DOCTOR NEEDED TO CHANGE GLOVES DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. NO PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8525610 ↗
• MalfunctionApr 17, 2019Material Fragmentation

  THE CUSTOMER REPORTED LINTING OF THE OR TOWELS PWTB03-STMA FROM THE CARDIAC CATHETER TRAY KIT SANDHCCCF2 DURING A CARDIAC CATHETERIZATION. THE PROCEDURE PROGRESSED CAUTIOUSLY DUE TO THE NEED TO OBSERVE FOR LINT ON WIRES, BALLOONS, STENTS AND GLOVES. STAFF AND DOCTOR NEEDED TO CHANGE GLOVES DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. NO PATIENT DEMOGRAPHICS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8525605 ↗
• MalfunctionApr 17, 2019Contamination /Decontamination Problem

  THE CUSTOMER REPORTED LINTING OF THE OPERATION ROOM TOWELS PWTB03-STMA FROM THE CARDIAC CATHETER TRAY KIT SANDHCCCF2 DURING A CARDIAC CATHETERIZATION. THE PROCEDURE PROGRESSED CAUTIOUSLY DUE TO THE NEED TO OBSERVE FOR LINT ON WIRES, BALLOONS, STENTS AND GLOVES. STAFF AND DOCTOR NEEDED TO CHANGE GLOVES DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. NO PATIENT DEMOGRAPHICS WERE PROVIDED. THE EVENT DATE WAS REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8522886 ↗