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Medtronic Xomed, Inc. FDA Recalls
15 recalls on file across devices, 4 of them Class I and 14 still open. Matched by name to MDT.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for Class IIJul 17, 2025Due to out of the box wobble of the driver. |
| NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Class IIMar 10, 2025Nerve Monitoring System with certain software versions has p |
| Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069Class IIJul 5, 2024Product was distributed past expiration date. |
| NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.Class IJun 24, 2024Potential for false negative response on the NIM Vital Nerve |
| NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; cClass IINov 7, 2023Firm received reports of customers experiencing noise from t |
| NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2Class IIMay 3, 2022Software anomaly was identified. |
| NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2Class IIMay 3, 2022Software anomaly was identified. |
| NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306Class IApr 29, 2022The firm received reports of events related to airway obstru |
| NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306JClass IApr 29, 2022The firm received reports of events related to airway obstru |
| NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506Class IApr 29, 2022The firm received reports of events related to airway obstru |
| NIM TRIVANTAGE EMG Endotracheal TubeClass IIDec 22, 2021There is potential for multiple issues due to a manufacturin |
| Software 1898072 IPC upgrade v 2.7.3.0, IPC System: a) CONSOLE 1898001 IPC, Product Number 1898001; b) CONSOLE IPC REFUClass IIDec 15, 2021As a result of Medtronic's integrated power console (authent |
| Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT NavigationClass IIAug 31, 2021There was an increase in complaints related to tip breaks an |
| Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT NavigationClass IIAug 31, 2021There was an increase in complaints related to tip breaks an |
| Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT NavigationClass IIAug 31, 2021There was an increase in complaints related to tip breaks an |