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
- Technomed Europe TE/S50715-001Technomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall2 reports
- Technomed Europe TE/S46-638Technomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall2 reports
- Technomed Europe TE/S50715-004Technomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall0 reports
- Technomed Europe TE/S50715-001-CTechnomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall0 reports
- N/A 8227410Medtronic Xomed, Inc. · Electrode, needle, diagnostic electromyograph12 reports
- Teca Elite S53153Natus Manufacturing Limited · Electrode, Needle, Diagnostic Electromyograph7 reports
- Dantec 9013S0032Natus Manufacturing Limited · Electrode, Needle, Diagnostic Electromyograph6 reports
- Dantec 9013S0042Natus Manufacturing Limited · Electrode, Needle, Diagnostic Electromyograph4 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.