Notes

FDA's Deadliest Recalls 2022 Unplaced Feeding Tubes The most feared (Avanos Medical)
Based on FDA recalls The Avanos medical Cortrak2 feeding tube is the highest-risk medical device.

Although 2022 isn't over, FDA already has 50 medical devices on its recall list. This recall resulted in 36 deaths and 224 injuries. Avanos Medical is first on the list of 2022 for malfunctions in medical devices, with 23 deaths attributed to misplaced feeding tubes.


They are the four most grave medical device malfunctions in accordance with the FDA recall notice.

Avanos Medical Recalls Cortrak*2 Enteral Access System for feeding tubes
A misplacement of the feed tubes for nasogastric patients led to 60 injuries and 23 deaths.

This device malfunction is the most significant cause of death in all medical devices that were recalled by the FDA in 2022.


Avanos Medical has pulled the Cortrak*2 Enteral Access System from service due to injuries and deaths resulting from the incorrect placement of nasogastric feed tubes.


Patients could suffer serious injury or even death, if a nasal tube or nasoenteric tub has been wrongly placed. To protect themselves, Avanos Medical sent an alert to healthcare providers, suggesting that the user or the hospital "...confirm the positioning of the NG/NI tubes according to hospital guidelines" Fox news reported.

Avanos Medical's recall announcement disclosed the deaths and injuries caused by the misplacement of the feed tubes to the stomach in the CORTRAK* 2 Enteral Access System since 2015.

Baxter recalls SIGMA Spectrum Infusion pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems With Dose IQ Safety (Version 9)
Baxter has received 51 reports of serious injuries. Avanos Medical There were three reports of patient deaths within the last five years possibly connected with this issue.

Avanos Mediacal Cortrak 2 After numerous complaints of safety alarms malfunctioning and malfunctions in safety alarms, the manufacturer of medical devices Baxter has announced a recall of this device. In the event of an obstruction to the flow of the water, the alarm failed to be activated on the pumps. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause These chemicals can trigger adverse health effects that could cause death, according to the announcement.

Medtronic Recalls EMG Reinforced Endotracheal Tube
There have been 3 accidents and 2 deaths attributed to the use of this device.

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube that are utilized to create an airway to the patient and monitor the laryngeal nerves undergoing head and neck surgeries - were responsible for three injuries and two deaths prior to Medtronic's recall. Although the company hasn't asked clients to return their defective devices or replace the devices, they did send out safety alerts to make sure the cuff made of silicone didn't hinder a patient's breathing.


If the tube is unable to effectively ventilate or blocks the airway, patients could suffer oxygen deprivation or brain damage. This could lead to death.

Baxter Healthcare Corporation Recalls Volara System
There was one death and 1 injury with the use of this device.

Baxter Healthcare Corporation, and Hillrom the subsidiary company, have recalled the Volara Systems. This is due to the fact that the adaptor used for in-line ventilators could not allow patients who use at-home ventilators to receive enough oxygen. The risks to affected patients include choking on mucus or other airway mucus, lung infection (pneumonia) that prevents oxygen from reaching the blood (respiratory failure) as well as brain injury due to a lack of oxygen to the brain (hypoxia), and death.


This is the number of lives lost in 2022 because of medical device malfunctions or misuse.


Avanos Medical Recalls Cortrak*2 Enteral Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps equipped with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) Occlusion-related events

Injuries: 51

Deaths: 3

Medtronic recalls NIM CONTACT Reinforced-EMG Endotracheal Tube, and the NIM Standards Reinforced-EMG Endotracheal Tube

Injuries: 3

Deaths: 2

Baxter Healthcare Corporation Recalls Volara System

Injuries: 1

Deaths: 2

Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps

Injuries: 7

Deaths: 1

Medtronic recalls the HeartWare HVAD System Batteries

Injuries: 6

Deaths: 1

Philips Respironics recalls all V60 and V60 Plus ventilators

Injuries: 4

Deaths: 1

Medtronic Recalls HVAD Pump Kit

Injuries: 2

Deaths: 1

Medtronic Recalls the HVAD Systems HeartWare Batteries

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm Recall of HawkOne Directional Atherectomy Systems

Injuries: 55

Deaths: 0

Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Thrombolytic Percutaneous Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation recalls iCast with a sten cover.

Injuries: 9

Deaths: 0

Vyaire Medical Recalls Bellavista 1000 Series and 1000e Series Ventilators

Injuries: 7

Deaths: 0

LivaNova (TandemLife) Recalls LifeSPARC System

Injuries: 2

Deaths: 0

Draeger, Inc Recalls SafeStar 55 Breathing System Filters

Injuries: 1

Deaths: 0

Abbott Medical Recalls Dragonfly OpStar Imaging Catheter

Injuries: 1

Deaths: 0

SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests

Injuries: 1

Deaths: 0

Cortrak 2 eternal access system
Read More: https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas