Weitz & Luxenberg is looking to hear from clients suffering injury from misplaced feeding tubes. The tubes were inserted using the recalled Avanos Medical Cortrak*2 Enteral Access System. Potential injuries include respiratory failure and other lung, esophagus, or bowel issues.

We would also like to hear from family members who lost a loved one due to the use of this defective device. The recall indicates that use of the Cortrak*2 Enteral Access System has unfortunately caused the death of many people.

Recall Based on Patient Complications

The Cortrak*2 Enteral Access System was recalled by the manufacturer, Avanos Medical, due to a risk that misplaced enteral tubes could harm patients. The device is used to help insert a feeding tube correctly. The recall instructs users — gastroenterologists, pulmonologists, and other health professionals — to confirm the tube is placed correctly before using it to deliver nutrition to patients. (1)

“Manufacturers have a duty to make sure the products their firms create and market meet safety requirements. Not only must they function correctly, but the instructions on how to use the device must be appropriate to ensure patient safety,” insists Ellen Relkin. “When manufacturers put making money above good patient care, someone has to stand up to them. I have dedicated my life to helping people who suffer due to the defects in medical devices supposedly designed to improve, not harm, their health.”

Ms. Relkin, a partner at our firm, is also the practice group chair for defective drugs and medical devices. She has spent decades litigating for clients who have been harmed by defective products. Ms. Relkin continues to be a court-appointed lead for many multidistrict litigations involving harmful devices used in the medical field.

Voluntary Recall Announced by Avanos

Avanos Medical recalled this device on March 21, 2022. The recall includes the Cortrak*2 Enteral Access System distributed between April 1, 2016 and January 1, 2022. There were 629 devices recalled in the U.S.

The U.S. Food and Drug Administration (FDA) identified this as a Class 1 recall on May 13, 2022. The FDA defines a Class 1 recall as “the most serious type of recall. Use of these devices may cause serious injuries or death.” (2)

Avanos Medical says the recall “is being used to make updates to the device’s labeling, including the instructions for use and intended uses.” (3)

According to the Avanos Urgent Field Correction, impacted products include: (4)

  • CORTRAK*2 Enteral Access System (EAS), Product Code 20-0950, UDI 00350770472010.
  • CORTRAK*2 Enteral Access System (EAS) – Loaner Unit, Product Code P20-0950, UDI 00350770472065.
  • CORTRAK*2 Enteral Access System (EAS) – Halyard version, Product Code 20-0950, UDI 10680651472011.
  • CORTRAK*2 Enteral Access System (EAS) – Loaner Unit – Halyard version, Product Code P20-0950, UDI 10680651472066.

Canadian Recall

In April 2022, the Government of Canada announced a Health Product Recall for the device. It is listed as recall class Type 1.

The recall states, “Avanos medical is conducting a voluntary field correction for the Cortrak* 2 Enteral Access System (Eas) because modifications to the labeling of the device have been initiated. Reports of injuries and patient deaths related to misplacement of nasogastric feeding tubes while operating the device per labeled instructions for use (IFU) and intended use have been received.” (5)

Health Problems Using the Cortrak Device

The recalled Cortrak device “is designed to help trained health care personnel place medical feeding tubes into the stomach or small bowel of patients” (6) so they can get necessary nutrition by using the tube. This is instead of eating or drinking by mouth.

The FDA announcement indicates, “If a nasogastric or nasoenteric tube is inserted incorrectly, patients could experience damage to the vocal cords, lungs, or trachea, all of which can lead to serious injury or death.”

Issues with these devices have been reported to the FDA. These negative health incidents include: (7)

  • Respiratory failure.
  • Collapsed lung.
  • Pneumonia.
  • Pleural effusion (excess fluid between the lungs and chest cavity).
  • Perforation (hole in the wall of the lung, esophagus, or bowel).

Contact Our Attorneys for Help with Avanos Recall

Numerous ill effects and deaths have been reported. This includes “60 injuries and 23 patient deaths related to misplacement of nasogastric feeding tubes while using the CORTRAK* 2 Enteral Access System, since 2015.” (8)

The attorneys on the defective medical device team at W&L are available to discuss this potentially deadly device recall with you. Clients should especially contact us if they are experiencing any respiratory or other symptoms after using this feeding device. Or if a loved one has died due to the device.

Reach out to our attorneys by phone at (833) 544-0604 or from our online form. There is no charge for an initial consultation to see if we can help you with your case.

Attorneys at Weitz & Luxenberg have successfully won more than $12 billion for our clients in drug and medical device litigation cases. Contact us to see how we can get you the help you need and deserve.

  1. U.S. Food & Drug Administration. (2022, May 13). Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
  2. Ibid.
  3. Ibid.
  4. Avanos. (2022, March 21). URGENT: FIELD CORRECTION. CORTRAK* 2 Enteral Access System (EAS). Retrieved from https://www.foxnews.com/health/health-tech-field-correction-fda-injury-death
  5. Government of Canada. (2022, April 109). Recalls and safety alerts. Health product recall. Cortrak*2 Enteral Access System (Eas). Retrieved from https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas
  6. U.S. Food & Drug Administration. (2022, May 13). Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
  7. Ibid.
  8. Avanos. (2022, March 21). URGENT: FIELD CORRECTION. CORTRAK* 2 Enteral Access System (EAS). Retrieved from https://www.foxnews.com/health/health-tech-field-correction-fda-injury-death

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