| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00691-1 |
| Product Name/Description |
Medtronic NIM CONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube
Model numbers: 8229506, 8229507, 8229508 and 8229307
ARTG 169809
(Medtronic Australasia Pty Ltd - Tube, tracheal, ventilation) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/05/2022 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic have received reports of events related to airway obstruction while using the NIM CONTACT Reinforced EMG Endotracheal Tube and and NIM Standard Reinforced EMG Endotracheal Tube. The NIM CONTACT and Standard Reinforced EMG Endotracheal Tubes are silicone tubes with the main shaft reinforced by a wire coil to prevent collapse while maintaining flexibility. The cuffs are also manufactured with silicone. Not following the Instructions for Use (IFU) and over-inflating the cuff increases intra-cuff pressure which can cause the silicone cuff to extend, herniate, or distort over the end of the tube and/or the murphy-eye potentially causing obstruction of the patient airway and loss of ventilation.
To date there have been multiple serious incidents, including patient deaths reported, connected to the above issue globally. There have been no complaints or adverse events reported in Australia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised to adhere to the Instructions for Use, and follow the recommended actions in the customer letter (provided to impacted customers by the sponsor) if using the endotracheal tube and airway obstruction is encountered:
- Immediately deflate the cuff and attempt to ventilate
- If ventilation cannot be re-established
a. Extubate the endotracheal tube from the patient
b. Re-establish ventilation with Bag Valve Mask (BVM) or Laryngeal Mask Airway (LMA).
c. Reintubate with a new non-silicone (PVC) Endotracheal Tube or, if surgically needed, re-intubate the patient with a new, larger NIM CONTACT tube which will require less cuff inflation volume and pressure.
The IFU is also in the process of being updated to reinforce the warnings/precautions, anticipated by May 2023. |
| Contact Information |
0419 695 557 - Mike Norris, Medtronic Australasia |