CARDINAL HEALTH SANHFACBMBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439318197), received between Dec 18, 2019 and Dec 20, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2019Contamination

  THE CUSTOMER REPORTED THAT LINT FROM THE BLUE, NON-X-RAY OR TOWELS PWTB04-STM IN THE ANGIOGRAPHY CATHETERIZATION PACK/ SANHFACBMB WAS FOUND ON THE TOWELS AND ON STAFF¿S GLOVES DURING A CARDIAC CATHETERIZATION. THERE WAS A DELAY OF APPROXIMATELY FIVE MINUTES TO SWITCH OUT THE TOWELS AND DROP NEW ONES INTO THE STERILE FIELD. NO INJURY WAS REPORTED. THE EVENT DATE WAS UNKNOWN BY THE CUSTOMER. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS PROACTIVELY FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9506186 ↗
• MalfunctionDec 18, 2019Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THAT LINT FROM THE BLUE, NON-X-RAY OR TOWELS PWTB04-STM IN THE ANGIOGRAPHY CATHETERIZATION PACK, WAS FOUND ON THE TOWELS PRIOR TO USE ON THE PATIENT. THE PROCEDURE TO BE PERFORMED WAS A CARDIAC CATHETERIZATION. THERE WAS A DELAY OF FIVE MINUTES TO SWITCH OUT THE TOWELS. NO INJURY WAS REPORTED. THE EVENT DATE WAS UNKNOWN BY THE CUSTOMER. ALTHOUGH THERE WAS NO INJURY, CARDINAL HEALTH IS PRO-ACTIVELY FILING A MEDWATCH REPORT FOR POTENTIAL RISK TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491905 ↗