CARDINAL HEALTH SNE40NACF1Recalls & reported problems
Cardinal Health 200, LLC · NEURO ANGIO PACK · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888439681475), received between Feb 14, 2020 and Feb 14, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
Device problems
- Material Fragmentation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 14, 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 DIAGNOSTIC ANGIOGRAM. 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. CARDINAL HEALTH IS FILING AN MDR FOR POTENTIAL RISK TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9714768 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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