Notes

FDA's most dangerous recalls of 2022 - Unplaced Feeding Tubes Leading (Avanos Medical)
Avanos Medical Cortrak2 feeding tubes are among the most lethal medical devices according to FDA recalls.

2022 isn't even close to an end, but the list of recalls by the FDA for medical devices has already reached 50. The effect of the recalls to date has been a tragic 36 deaths and 228 injuries. Avanos Medical ranks first on the 2022 list of medical device malfunctions , with 23 reports of deaths caused by feeding tubes that were not properly placed.


These are the four most serious malfunctions in medical devices, according to the FDA recall notice.

Avanos Medical Recalls Cortrak*2 Enteral Access System to feed tubes
The improper placement of nasogastric feeding tubes caused 60 injuries and 23 deaths.

Avanos Medical This is the leading cause of death in recalled devices.


Avanos Medical has recalled the Cortrak*2 Enteral Access System due to reports of injuries and deaths after nasoenteric or nasogastric feeding tubes have been improperly placed.


Patients may suffer serious injuries or even death if the nasogastric tube or nasoenteric tub is wrongly placed. Avanos Medical issued a notice to patients requesting that they verify the placement of the NG/NI tube according to hospital procedure. Fox news announced.

Avanos Medical reported in a recall notification that fatalities and injuries were caused by misplacement or the use of an feed tubes to the stomach while using the CORTRAK*2 Ental Access System.

Baxter recalls SIGMA Spectrum Infusion Systems with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems (Version 9)
Baxter has received 51 reports of serious injuries, and three deaths of patients within the last five years possibly connected with this problem.

Baxter, a manufacturer of medical devices recalls the device after numerous reports of a safety alarm failure. The alarms on the pumps was unable to activate in the event of upstream occlusions. A warning was issued that these products could cause adverse health effects and could even cause death.

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

The NIM CONTACT Reinforced EMG Endotracheal Tube as well as the NIM Standard Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube - both used to help provide airway and to monitor the laryngeal nerves during head or neck surgeries - were responsible for three injuries and two deaths before Medtronic's recall. Avanos Mediacal Cortrak 2 Avanos Medical feeding tube Although Medtronic doesn't ask customers to return damaged devices, it has sent out safety notices to help prevent the silicone cuff to block a patient's airway.


Patients can be affected by oxygen deprivation, brain damage or even death when the tube does not ventilate properly or block the airway.

https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview Baxter Healthcare Corporation Recalls Volara System
There have been one incident of injury and 2 deaths with the use of this device.

Baxter Healthcare Corporation, and Hillrom the subsidiary company, have recalled the Volara Systems. The reason for this is that the adaptor that is used to connect in-line ventilators might not permit patients using at-home devices to receive sufficient oxygen. The most vulnerable patients are those who breathe in mucus respiratory failure (pneumonia) as well as brain injury (hypoxia), and the possibility of choking.


Cortrak 2 eternal access system This list contains the human lives lost due to medical device misuse or malfunction in 2022.


Avanos Medical Remcalls Cortrak*2 Entry Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) & Spectrum IQ Infusion Systems With Dose IQ Safety Software(Version 9) occlusions

Injuries: 51

Deaths: 3

Medtronic recalls NIM CONTACT Reinforced Endotracheal Tube as well as the NIM Standards Reinforced-EMG Endotracheal Tube

Injuries: 3

Deaths: 2

Baxter Healthcare Corporation Recalls Volara System

Injuries: 1

Deaths: 2

Smiths Medical Remands Certain Medfusion 3500 & 4000 Syringe Pumps

Injuries: 7

Deaths: 1

Medtronic recalls the HeartWare HVAD System Batteries

Injuries: 6

Deaths: 1

Philips Respironics Recalls All V60 Ventilators

Injuries: 4

Deaths: 1

Medtronic recalls HVAD Pump Implant Kit

Injuries: 2

Deaths: 1

Medtronic recalls the HeartWare HVAD Systems Batteries

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Recalls HawkOne Directional Atherectomy System

Injuries: 55

Deaths: 0

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

Injuries: 14

Deaths: 0

Atrium Medical Corporation recalls iCast secured sten

Injuries: 9

Deaths: 0

Vyaire Medical Recalls bellavista 1000 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

https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical
Read More: https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns