CARDINAL HEALTH SANHFAGFTCRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888439507645), received between Sep 12, 2019 and Jul 20, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2020Material Fragmentation

  THE CUSTOMER REPORTED THAT DURING AN EMBOLIZATION IN THE LIVER/ SIRS SPHERES EMBOLIZATION, THERE WAS LINTING OF THE OR TOWELS PWTB04-STM FROM THE VASCULAR ANGIOGRAPHY PACK SANHFAGFTC ONTO THE WIRES THE TOWELS WERE USED TO HOLD WIRE AND CATHETER, TO PREVENT THEM FROM BOUNCING OFF THE TABLE AND TO HELP WITH ALL THE FLUID ON THE TABLE. THERE WAS NO DELAY IN PROCEDURE OR PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10299101 ↗
• MalfunctionJan 11, 2020Material Fragmentation

  PER CUSTOMER, PIECES OF LINT COMES OFF OF THE TOWEL AND ALLEGEDLY ARE LEAVING A LOT OF LINT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9579344 ↗
• MalfunctionOct 11, 2019Material Fragmentation

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER THE OR TOWELS ARE LINTING. REPORTEDLY THE FIBERS ARE BEING SEEN ON INSTRUMENTS. THERE HAS BEEN NO INJURY OR HARM TO PATIENT. THEY NOTED THE LINT BEFORE PROCEDURE AND REMOVED THE TOWELS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9180693 ↗
• MalfunctionOct 11, 2019Contamination /Decontamination Problem

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER THE OR TOWELS ARE LINTING. REPORTEDLY THE FIBERS ARE BEING SEEN ON INSTRUMENTS. THERE HAS BEEN NO INJURY OR HARM TO PATIENT. THEY NOTED THE LINT BEFORE PROCEDURE AND REMOVED THE TOWELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9180620 ↗
• MalfunctionSep 12, 2019Contamination /Decontamination Problem

  PER CUSTOMER REPORT, THE OR TOWELS ARE ALLEGEDLY LINTING. REPORTEDLY,THE FIBERS ARE BEING SEEN ON INSTRUMENTS. PER INFORMATION OBTAINED FROM THE CUSTOMER, THERE WERE NO INJURIES TO ANY PATIENT. THE LINT WAS WIPED OFF WITH A TELFA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9010489 ↗