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U.S. Department of Health and Human Services

Class 1 Device Recall NIM EMG Endotracheal Tube

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 Class 1 Device Recall NIM EMG Endotracheal Tubesee related information
Date Initiated by FirmApril 29, 2022
Date PostedSeptember 01, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1520-2022
Recall Event ID 90711
510(K)NumberK925640 
Product Classification Stimulator, nerve - Product Code ETN
ProductNIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
Code Information 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.
Recalling Firm/
Manufacturer
Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information ContactMarie Gentile
404-693-6028
Manufacturer Reason
for Recall
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 Determined
Cause 2
Under Investigation by firm
ActionMedtronic 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.
Quantity in Commerce1,133,612 units
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ETN
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