CARDINAL HEALTH SNE40NACFARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888439572568), received between Feb 26, 2020 and Feb 26, 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.

• MalfunctionFeb 26, 2020Contamination /Decontamination Problem

  THE CUSTOMER REPORTED EXCESSIVE AMOUNT OF LINT COMING OFF THE BLUE SURGICAL TOWELS PWTB04-STM FROM THE NEURO ANGIOGRAPHY PACK SNE40NACFA DURING A CASE ON A PATIENT WHO HAD A HISTORY OF A STROKE. THE CUSTOMER COULD NOT CONFIRM THE EXACT PROCEDURE PERFORMED. THE TOWELS WERE USED TO DRAPE OVER THE PATIENT AND LAYERED TO COVER THE DRIP LINES. SEVERAL PAUSES WERE NEEDED TO CLEAN THE LINT FROM GLOVES, CATHETERS, INSTRUMENTS AND SALINE BOWL. THERE WAS NO PATIENT INJURY. NO PATIENT DEMOGRAPHICS WERE PROVIDED AFTER SEVERAL ATTEMPTS TO OBTAIN. CARDINAL HEALTH IS FILING AN MDR FOR POTENTIAL RISK TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9759197 ↗
• MalfunctionFeb 26, 2020Material Fragmentation

  THE CUSTOMER REPORTED EXCESSIVE AMOUNT OF LINT COMING OFF OF THE BLUE SURGICAL TOWELS PWTB04-STM FROM THE NEURO ANGIOGRAPHY PACK SNE40NACFA DURING A CAROTID STENT PLACEMENT. THE TOWELS WERE USED TO DRAPE OVER THE PATIENT AND LAYERED TO COVER THE DRIP LINES. SEVERAL PAUSES WERE NEEDED TO CLEAN THE LINT FROM GLOVES, CATHETERS, INSTRUMENTS AND SALINE BOWL. THERE WAS NO PATIENT INJURY. NO PATIENT DEMOGRAPHICS WERE PROVIDED WHEN INQUIRED. THE EVENT DATE WAS UNKNOWN BY THE CUSTOMER. CARDINAL HEALTH IS FILING AN MDR FOR POTENTIAL RISK TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9759123 ↗