Medtronic Xomed, Inc.
6743 SOUTHPOINT DR. NORTH, Jacksonville, FL, US
Registered product codes
81 product codes
Recent MDR events
14,169 on file
- NIM Essence¿ EMG Endotracheal TubeJul 31, 2026Malfunction1045254-2026-01059
- IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4Jul 31, 2026Malfunction1045254-2026-01060
- XPS® BLADEJul 31, 2026Malfunction1045254-2026-01061
- NIM 4.0 CONSOLEJul 31, 2026Malfunction1045254-2026-01062
- XPS® BLADEJul 31, 2026Malfunction1045254-2026-01063
- NIM 4.0 CONSOLEJul 31, 2026Malfunction1045254-2026-01064
- NIM® 3.0 MAINFRAME INTERNATIONALJul 31, 2026Malfunction1045254-2026-01065
- NIM 4.0 CONSOLEJul 31, 2026Malfunction1045254-2026-01066
- NIM 4.0 CONSOLEJul 31, 2026Malfunction1045254-2026-01067
- NIM 4.0 CONSOLEJul 31, 2026Malfunction1045254-2026-01068
Recalls
38 on file
- Open, ClassifiedAug 27, 2025
Due to out of the box wobble of the driver.
View FDA record ↗ - Open, ClassifiedApr 18, 2025
Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical intervention.
View FDA record ↗ - Open, ClassifiedSep 12, 2024
Product was distributed past expiration date.
View FDA record ↗ - Open, ClassifiedJul 24, 2024
Potential for false negative response on the NIM Vital Nerve Monitoring System
View FDA record ↗ - Open, ClassifiedJan 10, 2024
Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
View FDA record ↗ - Open, ClassifiedSep 1, 2022
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
View FDA record ↗ - Open, ClassifiedSep 1, 2022
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
View FDA record ↗ - Open, ClassifiedSep 1, 2022
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
View FDA record ↗ - Open, ClassifiedJun 2, 2022
Software anomaly was identified.
View FDA record ↗ - Open, ClassifiedJun 2, 2022
Software anomaly was identified.
View FDA record ↗
Compliance history
Matched by FEI 1045254.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jun 17, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jun 17, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.100(a)Jun 17, 2024
Lack of or inadequate procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.