CARDINAL HEALTH SNE7AANAOARecalls & reported problems
Cardinal Health 200, LLC · ARNOT NEURO 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 10888439407297), received between Mar 24, 2020 and Mar 24, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionMar 24, 2020Break
CUSTOMER REPORTED THAT THE INTERWOVEN THREADS FROM XRAY GAUZE SPONGE C-NXR4416A FROM THE ARNOT NEURO PACK SNE7AANAOA ARE COMING APART AND WERE FOUND ON THE SURGICAL INSTRUMENTS DURING A BACK SURGERY. THE STERILE FIELD WAS REPLACED AND A COUNT OF SUPPLIES PERFORMED REQUIRING MINIMAL DELAY OF MINUTES PER CUSTOMER. THERE WAS NO INJURY OR ADVERSE EFFECT TO THE PATIENT. BASED ON POTENTIAL RISK TO THE PATIENT, CARDINAL HEALTH IS PROACTIVELY FILING AN MDR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9873813 ↗
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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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