Recall Z-1520-2022 ยท ETN Stimulator, Nerve
Medtronic Xomed, Inc.
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
| Date | Sep 1, 2022 (initiated Apr 29, 2022) |
| Status | Open, Classified |
| Reason | The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes. |
| Root cause | Under Investigation by firm |
| Action | Medtronic sent an URGENT: MEDICAL DEVICE SAFETY NOTICE to impacted customers on 29-APR-2022 by mail. The letter explained the problem and provided Recommended Actions when using NIM Standard Reinforced EMG Endotracheal Tube & NIM CONTACT" Reinforced EMG Endotracheal Tube and airway obstruction is encountered. Medtronic posted this issue to its US Product Performance and Advisories Information for Healthcare Professionals website on 3-May-2022. If you have any questions, contact your Medtronic ENT representative. Within the US, beginning 30-Jan-2024, Medtronic distributed a follow-up a notic |
| Quantity | 1,133,612 units |
| Distribution | Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Germany, Greece, Hong Kong, Hungary, Iceland, Ind |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925640 | XOMED-TREACE EMG ENDOTRACHEAL TUBEEN Xomed-Treace, Inc., Aug 17, 1993 |