NIM recallZ-1520-2022 · Medtronic Xomed, Inc. · initiated Apr 29, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Xomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
FDA root cause category: Under Investigation by firm
What the company is doing
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 notice via mail courier to all impacted consignees about availability of the updated IFU. On about 07/08/2024, Medtronic distributed an additional notification to consignees to notify them to remove all lots of the NIM Contact" EMG Reinforced Endotracheal Tubes and NIM" (Standard) EMG Reinforced Endotracheal Tubes. Customers were instructed to not use the affected devices and to identify, segregate, quarantine, and return affected products to Medtronic using the Customer Confirmation Form. https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/products/ear-nose-throat/nim-contact-emg-reinforced-endotracheal-tubes.pdf.
Recall details
- Recall number
- Z-1520-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 29, 2022
- Posted by the FDA
- Sep 1, 2022
- Recalling firm
- Medtronic Xomed, Inc.
- Quantity
- 1,133,612 units
- Product code
- ETN
- FDA submissions
- K925640
- 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, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Korea, Republic Of, Kosovo, Kuwait, Libya, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, North Macedonia, Northern Mariana Islands, Norway, Oman, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam
Product description
NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
Code information (models, lots, serial numbers)
a) REF 8229308; UDI 00643169789548, 00763000745837, 00763000882402; ALL LOTS. b) REF 8229307; UDI 00643169789531, 00763000745820, 00763000882396; ALL LOTS. c) REF 8229306; UDI, 00643169789524, 00763000745813, 00763000882389; ALL LOTS.
Devices named in this recall
9 devices in the FDA device registry whose identifier appears in the recall's code information.
- NIM® 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall1 death167 reports
- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall138 reports
- NIM 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall29 reports
- NIM® 8229308Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall13 reports
- NIM 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall11 reports
- NIM 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall7 reports
- NIM 8229308Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall2 reports
- NIM 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall2 reports
- NIM 8229308Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall0 reports
Product lines
Other devices under the same FDA submission
6 devices cleared under K925640 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NIM FLEX™ 8229970Medtronic Xomed, Inc. · STIMULATOR, NERVE11 reports
- NIM FLEX™ 8229975Medtronic Xomed, Inc. · STIMULATOR, NERVE8 reports
- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE2 reports
- NIM FLEX™ 8229965Medtronic Xomed, Inc. · STIMULATOR, NERVE2 reports
- NIM FLEX™ 8229980Medtronic Xomed, Inc. · STIMULATOR, NERVE2 reports
- NIM FLEX™ 8229985Medtronic Xomed, Inc. · STIMULATOR, NERVE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 90711).
- Z-1519-2022 · Open, ClassifiedNIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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