Skip to content
Recall Observatory FDA recall evidence

Device product

NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306

Z-1520-2022

April 29, 2022

Class I

Product summary

Firm
Medtronic Xomed, Inc.
Event
Event 90711
Status
Ongoing
Classification
Class I
Quantity
1,133,612 units
Official record key
device-enforcement:Z-1520-2022

Official wording

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.

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.

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.