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IO-FLEX
SPINAL ELEMENTS · Model iO-NCW · UDI-DI 00840916103804
1
510(k) clearances
5,083
Adverse events (11 deaths)
31
Recalls
141
Facilities
Description
IO-Flex Neuro Check® w/ Wire
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-19 | Neurovision Medical Products Inc | Product packaging contains the wrong part number and kit contents. |
| 2025-02-24 | Checkpoint Surgical Inc | Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electri |
| 2025-02-24 | Checkpoint Surgical Inc | Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electri |
| 2024-07-25 | Technomed Europe | Product has have presence of brown discoloration or substance on the hinge area of the device |
| 2024-07-01 | Neurovision Medical Products Inc | mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. |
| 2023-11-07 | Medtronic Xomed, Inc. | Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring, |
| 2022-04-29 | Medtronic Xomed, Inc. | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. |
| 2022-04-29 | Medtronic Xomed, Inc. | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. |
| 2022-04-29 | Medtronic Xomed, Inc. | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. |
| 2021-12-22 | Medtronic Xomed, Inc. | There is potential for multiple issues due to a manufacturing nonconformity. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.