CARDINAL HEALTH PN11NEXXERecalls & reported problems
Cardinal Health 200, LLC · KIT, NEURO SJMC · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10195594483074), received between Jul 22, 2022 and Jul 22, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Nov 8, 2024Class IIOpen, Classified
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Z-1134-2025 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2022Material Separation; Detachment of Device or Device Component; Material Separation
CUSTOMER REPORTED FIBERS FROM THE GAUZE KC7317AP IN THE NEURO KIT PN11NEXXE CAME LOOSE AND WERE FOUND WITHIN THE PATIENT VIA THE SURGICAL INCISION SITE. THERE WAS NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED WHEN REQUESTED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 15087926 ↗
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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 · each recall links to the FDA recall notice
- 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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