Chrysalis Intelligence · Sponsors · Medtronic Xomed, Inc.

Medtronic Xomed, Inc.

Jacksonville, FL, US · 7 510(k) clearances · 16 recalls (4 Class I)

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Total clearances
7
2020-10-28 → 2026-02-10
Last 12 months
1
Product codes
4
Most recent
2026-02-10
Name variants in FDA filings: Medtronic Xomed, Inc. / Medtronic Xomed
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ETN — — — 4 2026-02-10
PNZ Eustachian Tube Balloon Dilation Device Class II Ear, Nose, Throat 1 2021-08-16
LYA Splint, Intranasal Septal Class I Ear, Nose, Throat 1 2020-12-08
GWF Stimulator, Electrical, Evoked Response Class II Neurology 1 2020-10-28
Safety

Recalls (16)

Class I (serious)
4
Risk of injury / death
Total recalls
16
Currently ongoing
14
Most recent
2025-07-17
DateSeverityStatusRecall # ProductCodeReason
2025-07-17 Class II Ongoing Z-2461-2025 IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for … — Due to out of the box wobble of the driver.
2025-03-10 Class II Ongoing Z-1623-2025 NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, … — Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedu…
2024-07-05 Class II Ongoing Z-3130-2024 Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 — Product was distributed past expiration date.
2024-06-24 Class I Ongoing Z-2409-2024 NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.… — Potential for false negative response on the NIM Vital Nerve Monitoring System
2023-11-07 Class II Ongoing Z-0696-2024 NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c… — Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
2022-05-03 Class II Ongoing Z-1224-2022 NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 — Software anomaly was identified.
2022-05-03 Class II Ongoing Z-1223-2022 NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 — Software anomaly was identified.
2022-04-29 Class I Ongoing Z-1521-2022 NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J — The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotr…
2022-04-29 Class I Ongoing Z-1520-2022 NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306 — The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotr…
2022-04-29 Class I Ongoing Z-1519-2022 NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506 — The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotr…
2021-12-22 Class II Ongoing Z-0743-2022 NIM TRIVANTAGE EMG Endotracheal Tube — There is potential for multiple issues due to a manufacturing nonconformity.
2021-12-15 Class II Terminated Z-0961-2022 Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFU… — As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that…
2021-08-31 Class II Ongoing Z-0158-2022 Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation… — There was an increase in complaints related to tip breaks and wobble/vibration.
2021-08-31 Class II Ongoing Z-0157-2022 Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation… — There was an increase in complaints related to tip breaks and wobble/vibration.
2021-08-31 Class II Ongoing Z-0156-2022 Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation… — There was an increase in complaints related to tip breaks and wobble/vibration.
2020-06-12 Class II Terminated Z-2673-2020 Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, dr… — During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a hi…
Filings

All 510(k) clearances (7)

Date K-number Device Code Class Specialty
2026-02-10 K251672 NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080) ETN — —
2023-10-26 K230320 NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube ETN — —
2023-08-30 K231580 NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) ETN — —
2022-03-21 K213246 NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long ETN — —
2021-08-16 K210841 NuVent Eustachian Tube Dilation Balloon PNZ Class II Ear, Nose, Throat
2020-12-08 K202623 Novapak Nasal Sinus Packing and Stent LYA Class I Ear, Nose, Throat
2020-10-28 K200759 NIM Vital, Nerve Integrity Monitor GWF Class II Neurology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence