NVM5 1559165Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517116239), received between Apr 16, 2026 and Apr 16, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K143641); they may or may not involve this specific model.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Biocompatibility; Device Markings/Labelling Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT IT HAS BEEN DISCOVERED THAT THE NEEDLE ALLOY IN THE NUVASIVE DUAL NEEDLE ELECTRODE SETS CONTAIN NICKEL WHICH IS NOT IDENTIFIED ON THE LABEL. A PATIENT UNDERGOING A SPINAL PROCEDURE HAD AN ANAPHYLAXIS REACTION TO THE PRODUCT. THE REPS WERE MADE AWARE OF NICKEL ALLERGY IN TEAM BRIEF BY ANESTHETIST RAISING QUESTIONS ABOUT NEEDLES AND NICKEL CONTENT. THE REP MADE CALLS TO GET CERTAINTY OF PRESENCE OF NICKEL. ULTIMATELY THE TEAM USED THE GEL ELECTRODE PATCHES, NOT THE NEEDLES, AND MOVED THE NVM5 UNIT FROM QE TO USE WITH GEL PATCHES, AS THEY WOULD NOT STRETCH TO THE PULSE MACHINE AT THE HOSPITAL. THE PT WAS UNDER ANAESTHETIC WAITING BEFORE NVM5 UNIT ARRIVED - ESTIMATED EXTRA 20 MINS ANAESTHETIC TIME. ONLY GEL PATCH ELECTRODES WERE USED FOR THE CASE, AND NO NEEDLES WERE INSERTED INTO PATIENT.

  Patient problems: Anaphylactoid / Anaphylaxis

  MAUDE report 24895491 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143641. One submission often covers many models, so check the product and lot details in each record.

• Z-2684-2020 · Jun 10, 2020 · Terminated
  Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal s