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U.S. Department of Health and Human Services

Class 1 Device Recall NIM CONTACT

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  Class 1 Device Recall NIM CONTACT see related information
Date Initiated by Firm April 29, 2022
Date Posted September 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-1519-2022
Recall Event ID 90711
510(K)Number K925460  
Product Classification Stimulator, nerve - Product Code ETN
Product NIM CONTACT EMG Endotracheal Tube, Part Numbers:
a) REF 8229508
b) REF 8229507
c) REF 8229506
Code Information a) REF 8229508, UDI 00643169789579, 00763000745868, ALL LOTS; b) REF 8229507, UDI 00643169789562, 00763000745851, ALL LOTS; c) REF 8229506, UDI 00643169789555, 00763000745844, ALL LOTS
Recalling Firm/
Manufacturer		 Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information Contact Marie 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
Action Medtronic initiated an "URGENT: MEDICAL DEVICE SAFETY NOTICE" to impacted customers on 29-APR-2022 by mail. The letter explained the problem and provided the following: Recommended Actions when using NIM Standard Reinforced EMG Endotracheal Tube & NIM CONTACT Reinforced EMG Endotracheal Tube and airway obstruction is encountered: 1. Immediately deflate the cuff and attempt to ventilate. 2. If ventilation cannot be re-established: a. Extubate the NIM Standard Reinforced EMG Endotracheal Tube or NIM CONTACT Reinforced EMG 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 Standard Reinforced EMG Endotracheal Tube or NIM CONTACT Reinforced EMG Endotracheal Tube which will require less cuff inflation volume and pressure. Additional Discussion for Using a NIM Standard Reinforced EMG Endotracheal Tube & NIM CONTACT Reinforced EMG Endotracheal Tube: Intubate the patient using standard of care and medical training and knowledge. As stated in the IFU, use care when manipulating the tube's position. Manipulation of an inflated tube can cause the inflated cuff to stretch over the tube opening potentially causing obstruction to the patient's airway. Any manipulation or repositioning of the tube and/or patient should be preceded by deflation of the cuff. Then assess tube placement and non-occlusion to help ensure successful ventilation. The letter included language from the warnings and precautions sections of the IFU. Copies of the updated IFU will be disseminated upon availability. 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
Quantity in Commerce 55051 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, 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 Cycle TPLC 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) Database 510(K)s with Product Code = ETN and Original Applicant = SYNTHES (USA)
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