| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00929-1 |
| Product Name/Description |
NIM Standard Reinforced EMG Endotracheal Tube
Product Codes: 8229506, 8229507, 8229508
ARTG Number: 169809 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic have received reports (reported rate is 0.017%) of EMG Endotracheal Tubes, where the ends of electrode wires at the distal end of the tube have extruded through the wall of the tube, entering the cuff and/or puncturing through the cuff and becoming exposed. Four (4) of these complaints involved serious injuries, where an extruded/protruding electrode wire penetrated the tracheal wall or a vocal cord (3 reports overseas); or caused cuff deflation and required re-intubation of the patient (1 report in USA). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The current Instructions for Use (IFU) is in the process of being updated to reinforce the warnings/precautions with information relative to this bending issue. Users are advised to:
· Do not excessively bend the EMG tube, particularly at an acute angle (less than 90°). Excessive bending may cause the wire electrodes to protrude through the tube puncturing through the cuff and becoming exposed. This may result in serious injuries where the exposed wire can penetrate the tracheal wall or a vocal cord, or cause cuff deflation which will require re-intubation of the patient.
The copy of the updated IFU will be mailed to the customers, as soon as it becomes available. This action has been closed-out on 02/03/2017. |
| Contact Information |
07 3025 3549 - Medtronic |