FDA Medical Device Recalls (openFDA)
Medtronic Xomed, Inc.: NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
- Recall number
- Z-0901-2017
- Recalling firm
- Medtronic Xomed, Inc.
- Product
- NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
- Status
- Terminated
- Initiated
- 2016-06-28
- Posted
- not on file
- Terminated
- 2019-08-07
- Reason
- Wire in tubing can become exposed, posing potential harm to the intubated patient.
- Root cause
- Use error
- Action
- Medtronic sent an Urgent Product Safety Advisory letter dated June 28, 2016, to all affected customers informing them of the correction and providing instruction to avoid causing injury when using the EMG Endotracheal Tube. Recommended Actions included: inspecting the product thoroughly before use, testing the cuff by inflating it then deflating it before intubation, using a non-malleable stylet that closely matches the natural curve of the tube, not bending and flexing the tube excessively before use, and lubricating the cuff with a non-paralyzing, aqueous lubricant and a lubricated stylet. If customers found an EMG tube that appeared to have an electrode wire protruding from the distal end, the tube is not to be used and practitioners are urged to call Medtronic Product Quality Experience Department at 1-866-849-4003. For further questions , please call (904) 296-9600.
- Quantity
- 3752
- Distribution
- Worldwide Distribution - Nationwide Distribution including US Virgin Island and Puerto Rico , and to the countries of :Japan, Korea, China, Canada, Dominican Republic, Colombia, Chile, Costa Rica, Bahamas, Peru, Panama, Mexico, Argentina, Ecuador, Brazil, Trinidad and Tobago, Hong Kong, Taiwan, United Kingdom, Netherlands, Sri Lanka, Austria, Italy, Germany, United Arab Emirates, Saudi Arabia, Kuwait, France, Belgium, Oman, Ireland, Azerbaijan, India, Spain, Portugal, Luxembourg, Switzerland, Russian Federation, Austria, Greece, Cyprus, Portugal, India, Algeria, Iceland, Iran, Denmark, Hungary, Czech Republic, Ukraine, Turkey, Croatia, Israel, Norway, Oman, Sweden, Libya, Finland, Spain, Portugal, Algeria, Morocco, Poland, Canada, Malaysia, Singapore, Australia, and New Zealand
- Lot, serial or model codes
- All lots distributed since May 2012. Catalog Ref No. (reinforced standard tubes) 82-29306, 82-29307, & 82-29308; Catalog Ref No. (reinforced standard tubes, Japan) 8229306J, 8229307J, & 8229308J; Catalot Ref No. (reinforced contact tubes) 8229506, 8229507, & 8229508;
- 510(k) numbers
- ["K925640"]
- PMA numbers
- not on file
- Product code
- ETN
- Firm FEI
- 1045254
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28