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NEURAY ® 8004000Recalls & reported problems

Medtronic Xomed, Inc. · PACKING 8004000 NEURAY 200PK 13X13MM · Class 2

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 00643169931985), received between Jan 9, 2020 and Jan 9, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Separation1

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.

  • MalfunctionJan 9, 2020Material Separation; Material Separation

    A HEALTH CARE PROVIDER (HCP) REPORTED THAT ON A ARTHROPLASTY. A DEVICE'S PATTIES WERE COMING OFF OF THE STRINGS. THERE WAS NO PATIENT IMPACT. UPON FOLLOW UP IT WAS CONFIRMED THAT PATTIES WERE USED ON A PATIENT DURING AN ARTHROPLASTY. IT WAS DURING THE PROCEDURE WHEN THE RN IDENTIFIED THAT THE PATTIES WERE COMING OFF OF THE STRINGS. HERE WAS NO IMPACT TO PATIENT OR STAFF BECAUSE THIS PROBLEM WAS IDENTIFIED DURING THE PROCEDURE. HIS PRODUCT WAS DISCARDED DURING THE CASE DUE TO IT BEING CONTAMINATED WITH BLOOD.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9568144 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.