CARDINAL HEALTH SANHFCAUIBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887488864280), received between Jul 10, 2020 and Jul 10, 2020 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2020Contamination /Decontamination Problem

  CUSTOMER REPORTED LINTING OF THE OPERATING ROOM TOWELS PWTB04-STM FROM THE CATH ANGIO PACK SANHFCAUIB DURING A FISTULAGRAM PROCEDURE. LINT WAS FOUND ON THE PHYSICIAN AND STAFF¿S GLOVES. THERE WAS NO PATIENT INJURY. REPORT BEING FILED FOR RISK TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10257291 ↗
• MalfunctionJul 10, 2020Material Fragmentation

  CUSTOMER REPORTED LINTING OF THE OPERATING ROOM TOWELS PWTB04-STM FROM THE CATH ANGIO PACK SANHFCAUIB DURING A UTERINE FIBROID EMBOLIZATON PROCEDURE. LINT WAS FOUND ON THE GLOVES OF THE PHYSICIAN AND STAFF. THERE WAS NO PATIENT INJURY. REPORT BEING FILED FOR RISK TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10257249 ↗