Reports describe airway obstruction, ventilation failure, brain injury and death in patients intubated with Medtronic NIM Standard and NIM Contact Reinforced EMG endotracheal tubes. The FDA said it had received reports of serious adverse events and deaths with these devices.
Medtronic began the recall in April 2022. The FDA classified the recall of these tubes as Class I, the most serious type. Medtronic removed all lots in July 2024, and the FDA told providers not to use them.
No lawsuit, MDL or class action names these tubes. Schmidt & Clark can review possible injury claims from patients who were intubated with these tubes.
- Case or litigation name: No filed lawsuit; Medtronic NIM EMG endotracheal tube recall and claim review
- Defendants: Medtronic (none named in a court case)
- Court and docket number, when available: No filed case
- MDL number, judge, and case count, when an MDL exists: No MDL
- Filing date: No filing yet
- Main allegations: Reports that the silicone cuff can block the tube (consistent with cuff herniation, in some cases from overinflation), leading to airway obstruction, ventilation failure, oxygen deprivation, brain injury or death; reports from Medtronic and the FDA, not court allegations
- Products or people involved: Medtronic NIM Standard and NIM Contact Reinforced EMG Endotracheal Tubes (models 8229306, 8229307, 8229308, 8229506, 8229507, 8229508, 8229306J, 8229307J, 8229308J); patients intubated with them
Table Of Contents
- Latest Medtronic Endotracheal Tube Lawsuit Updates
- November 22, 2024: FDA Classifies the Recall as Class I
- July 9, 2024: Medtronic Recalls All Lots
- February 21, 2024: FDA Updates on Medtronic Follow-Up Letter
- September 16, 2022: FDA Updates on the Voluntary Recall
- September 12, 2022: FDA Issues a Class I Recall Notice
- April 29, 2022: Medtronic Starts the Recall
- April 27, 2022: FDA Writes to Health Care Providers
- What Is an EMG Endotracheal Tube?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Potential Compensation
- Frequently Asked Questions
- References
Latest Medtronic Endotracheal Tube Lawsuit Updates
November 22, 2024: FDA Classifies the Recall as Class I
The FDA classified Medtronic‘s July 2024 recall of the NIM Standard and NIM Contact EMG endotracheal tubes as a Class I recall [1]. Class I is the most serious type of recall.
July 9, 2024: Medtronic Recalls All Lots
On July 9, 2024, Medtronic issued an Urgent Medical Device Recall notice. It removed all NIM Standard and NIM Contact EMG endotracheal tubes from inventory because of tube blockage [2].
The FDA letter that day told providers not to use the tubes and to return any in their inventory to Medtronic. It also asked providers to report problems with the devices to the FDA.
February 21, 2024: FDA Updates on Medtronic Follow-Up Letter
On February 21, 2024, the FDA gave an update on Medtronic’s follow-up customer letter. The letter carried updated instructions for use and new training material, including what to do when airway obstruction has occurred.
Respiratory Therapy reported the update the next day [3]. The update advised using less than 5 mL of air to inflate the cuff if re-intubating with an EMG tube.
September 16, 2022: FDA Updates on the Voluntary Recall
On September 16, 2022, the FDA gave an update to make sure health care providers were aware of the voluntary recall. Medtronic had started that recall, also called a correction, for the risk of airway obstruction.
September 12, 2022: FDA Issues a Class I Recall Notice
On September 12, 2022, the FDA issued a Class I recall notice for the NIM Contact and NIM Standard Reinforced EMG endotracheal tubes. The risk was airway obstruction.
The notice covered 53,029 devices in the U.S. and 339,260 outside the U.S. It said use of these devices may cause serious injuries or death [4].
April 29, 2022: Medtronic Starts the Recall
On April 29, 2022, Medtronic started the recall and issued an Urgent Medical Device Safety Notice. The notice stressed the instructions for use and avoiding overinflation of the silicone cuff.
April 27, 2022: FDA Writes to Health Care Providers
On April 27, 2022, the FDA sent a letter to health care providers. It covered the potential risk of airway obstruction with the Medtronic NIM EMG tubes. The FDA said it was evaluating the risk.
What Is an EMG Endotracheal Tube?
According to the FDA, EMG endotracheal tubes have electrodes. The electrodes monitor nerves to the laryngeal musculature. The tubes give patients an airway for ventilation during surgery.
These devices are 510(k) cleared and made from either PVC or silicone elastomer. In its April 2022 letter, the FDA named Medtronic’s NIM Standard and NIM Contact tubes as the silicone-based EMG tubes marketed in the U.S. [5].
Who May Be Affected?
Patients who were intubated with a NIM Contact Reinforced or NIM Standard Reinforced EMG endotracheal tube may be affected. The 2022 recall covered tubes distributed from April 26, 2018 to April 15, 2022.
Reported outcomes include airway obstruction, hypoxia, brain injury and death. Whether an injury relates to a tube depends on medical records and an individual legal review. See our guide to medical device lawsuits.
Reported Injuries or Damages
In its July 9, 2024 letter, the FDA listed reported hazards, including airway obstruction, unintended extubation, bronchospasm, hypoventilation and hypoxia.
The letter also listed low oxygen saturation, respiratory distress, abnormal blood gas measurements, cyanosis, apnea, respiratory arrest, cardiac arrest, brain injury and death.
Medtronic reported 15 complaints, three injuries and two deaths between March 31, 2020 and March 31, 2022. Medtronic’s July 2024 notice reported 77 complaints between March 31, 2020 and May 20, 2024.
These are manufacturer complaint counts and regulator reports. They are not court findings or proof that the tubes caused each event.
In its April 27, 2022 letter, the FDA said reports suggested airway obstruction was more frequent with silicone-based EMG tubes. It had no similar reports for PVC tubes and noted the limits of the data.
Recall and Regulatory Background
The recall covers NIM Contact and NIM Standard Reinforced EMG endotracheal tubes in nine models: 8229306, 8229307, 8229308, 8229506, 8229507, 8229508, 8229306J, 8229307J and 8229308J.
Medtronic recalled the tubes after complaints about obstruction in patients. Its 2024 notice cites tube blockage, consistent with cuff herniation, in some cases due to overinflation of the cuff.
A recall does not by itself establish liability, and no court case names Medtronic over these tubes. Report problems to the FDA through MedWatch.
Evidence to Preserve
Keep any records that show which tube was used and what happened afterward, and store copies in a safe place:
- Model number, lot number and unique device identifier from the device record or box
- Hospital, surgery and anesthesia records showing which tube was used
- Medical records of the airway event, breathing support, oxygen levels and any brain injury or death
- Bills for treatment after the event
- Any report made to the hospital, Medtronic or MedWatch
- Photos of the patient, the tube or the box
- Dated notes and messages about the event
Filing Deadlines
Filing deadlines exist for injury claims, and they come from state law. How long you have depends on where you live and when the injury or death and its cause were identified.
Letting a deadline pass can end a claim, even one built on strong facts. Check with a lawyer soon to learn which deadline governs your situation.
Potential Compensation
A medical device injury claim may seek damages. The categories depend on the facts of each case. They can include medical expenses, lost income and pain and suffering.
In a death case, damages may also cover funeral costs. They may also cover loss of a loved one’s support and companionship.
Compensation amounts vary by case. Past results do not guarantee future outcomes. Potential compensation for an airway injury would depend on the treatment records.
Frequently Asked Questions
What Did Medtronic Change Before the 2024 Recall?
Before the 2024 recall, Medtronic issued a follow-up safety notice in January 2024. It added training through Medtronic Academy and updated the instructions for use of the endotracheal tubes for surgeons and hospitals.
How Can I Report a Problem with a Medtronic Endotracheal Tube?
You can report a problem with a Medtronic endotracheal tube through MedWatch, the FDA’s safety information and adverse event reporting program. The FDA recall database also lists the devices, so you can match a tube to the recall entry.
What Does the Research Say About Medtronic Endotracheal Tube Injuries?
Research on Medtronic endotracheal tube injuries comes from reports, not studies. The FDA, drawing on medical device reports (MDRs), said the root cause and incidence rate of airway obstruction were not known at that time.
What Did the FDA Advise About Cuff Inflation on Medtronic Endotracheal Tubes?
The FDA update on Medtronic endotracheal tubes advised verifying intracuff pressure if a patient is re-intubated with an EMG tube. It also advised inflating the cuff with only a small volume of air.
References
- https://www.fda.gov/medical-devices/letters-health-care-providers/do-not-use-medtronic-nim-standard-and-contact-emg-endotracheal-tubes-letter-health-care-providers
- https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/products/ear-nose-throat/nim-contact-emg-reinforced-endotracheal-tubes.pdf
- https://respiratory-therapy.com/products-treatment/monitoring-treatment/therapy-devices/medtronic-updates-recommendations-for-airway-obstruction-risk-in-certain-endotracheal-tubes/
- https://web.archive.org/web/20230129061432/https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-nim-contact-reinforced-emg-endotracheal-tube-and-nim-standard-reinforced-emg
- https://web.archive.org/web/20240625230549/https://www.fda.gov/medical-devices/letters-health-care-providers/potential-risk-airway-obstruction-when-using-certain-electromyogram-endotracheal-tubes-letter-health