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Neuroline ConcentricNeurology Needle Electrodes 74025-30/25Recalls & reported problems

Ambu A/S · Neurology needle electrodes · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05707480023653), received between Feb 2, 2023 and Feb 2, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1
  • Mechanical Problem1

Patient problems

  • Foreign Body In Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 2, 2023Mechanical Problem; Mechanical Problem

    DURING A ROUTINE NEEDLE ELECTROMYOGRAPHY (EMG) PROCEDURE, WHILE EXAMINING THE LEFT ILIOPSOAS MUSCLE, THE CONCENTRIC NEEDLE BROKE OFF OF THE NEEDLE HUB. THIS INCIDENT OCCURRED DURING THE PORTION OF THE MOTOR UNIT ACTIVATION EXAM, WHERE THE HIP IS FLEXED UPWARDS WITH THE NEEDLE IN THE MUSCLE. THE ADIPOSE TISSUE THERE REQUIRES DEEPER PENETRATION OF THE NEEDLE. THE PATIENT DID NOT REPORT DISCOMFORT. X-RAY REVEALED EVIDENCE OF THE NEEDLE FRAGMENT PRESENT IN THE PROXIMAL LEFT THIGH. PATIENT WAS EVALUATED AT A LOCAL EMERGENCY ROOM (ER) WHERE NO URGENT ACTION WAS REQUIRED. PATIENT IS AWAITING URGENT OUTPATIENT SURGERY EVALUATION FOR REMOVAL OF THE FOREIGN OBJECT.

    Patient problems: Foreign Body In Patient

    MAUDE report 16284501 ↗
  • MalfunctionFeb 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    DURING A ROUTINE NEEDLE ELECTROMYOGRAPHY (EMG) PROCEDURE, WHILE EXAMINING THE LEFT ILIOPSOAS MUSCLE, THE CONCENTRIC NEEDLE BROKE OFF OF THE NEEDLE HUB. THIS INCIDENT OCCURRED DURING THE PORTION OF THE MOTOR UNIT ACTIVATION EXAM, WHERE THE HIP IS FLEXED UPWARDS WITH THE NEEDLE IN THE MUSCLE. THE ADIPOSE TISSUE THERE REQUIRE DEEPER PENETRATION OF THE NEEDLE. THE PATIENT DID NOT REPORT DISCOMFORT. X-RAY REVEALED EVIDENCE OF THE NEEDLE FRAGMENT PRESENT IN THE PROXIMAL LEFT THIGH. PATIENT WAS EVALUATED AT A LOCAL EMERGENCY ROOM (ER) WHERE NO URGENT ACTION WAS REQUIRED. PATIENT IS AWAITING URGENT OUTPATIENT SURGERY EVALUATION FOR REMOVAL OF THE FOREIGN OBJECT.

    Patient problems: Foreign Body In Patient

    MAUDE report 16282582 ↗

Other Electrode, needle, diagnostic electromyograph devices

All Electrode, needle, diagnostic electromyograph devices →

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