Notes

FDA's most dangerous recalls of 2022 - Food Feeding Tubes Inspiring (Avanos Medical)
As per FDA recalls, Avanos ' Medical Cortrak2 is the most hazardous medical device.

2022 hasn't yet come to an end, but the FDA's list of recalled medical devices is currently at 50. These recalls have resulted in 36 deaths and 228 injuries. Avanos Medical feeding tube Avanos Medical ranks first on the list of 2022 medical device malfunctions with 23 cases of deaths caused by feeding tubes that were not properly placed.


These are the 4 most dangerous medical device errors according to the FDA recall notice:

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
The misplacement of the nasogastric feed tube resulted in 60 injuries and 23 fatalities.

This is the most frequent cause of death for recalls of devices.


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


Patients may suffer serious injuries or even death if the nasogastric tub or nasoenteric tube is wrongly placed. Avanos Medical issued a note to the healthcare providers to verify the placement of the NG/NI tube according to hospital guidelines. Fox news reported.

Avanos Medical's recall notification included the fatalities and injuries due to the misplacement the feeding tubes for the enteral system during the use of the CORTRAK* 2 Enteral Access System from 2015.

Baxter recalls SIGMA Spectrum Infusion Systems, which includes Master Drug Library (Version 8) & Spectrum IQ Infusion Systems (Version 9)
Baxter has received 51 complaints about serious injuries and three reports of deaths in patients which could be linked to this issue in the last five years.

Following numerous complaints about malfunctioning safety alarms, the manufacturer of medical devices Baxter has announced a recall of the device. Alarms on the pumps weren't activated in the event of upstream occlusion events. These substances can have adverse health consequences that could lead to death as per the announcement.

Medtronic Recalls EMG Reinforced Endotracheal Tube
This device has been associated with three injuries and two deaths.

feeding tube placement The NIM CONTACT Reinforced EMG Endotracheal Tube as well as the NIM Standard Reinforced EMG Endotracheal Tube These tubes are utilized to create an airway as well as monitor laryngeal nerves during head and neck surgeries - have been the cause of three injuries and two deaths in the lead up to Medtronic's recall. Cortrak 2 eternal access system Although Medtronic doesn't ask customers to return damaged devices, it has sent out safety notices in an effort to stop the cuff made of silicone from blocking a patient’s airway.


Patients can suffer from cerebral injury, oxygen deprivation, or even die if the tube is not properly ventilated.

Avanos Mediacal Cortrak 2 Baxter Healthcare Corporation Recalls Volara System
The use of this device led to 2 injuries and 2 deaths.

https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://aacnjournals.org/ajcconline/article/26/2/149/3230/Cortrak-Assisted-Feeding-Tube-Insertion-A Baxter Healthcare Corporation, and Hillrom its subsidiary company, have recalled the Volara Systems. This is because the adaptor for inline ventilators may not allow home-use patients to get enough oxygen. Patients at risk include those who breath in mucus and respiratory failure (pneumonia), brain injuries (hypoxia), and coughing.


Avanos Medical This is a listing of human life lost because of 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 NIMCONTACT Reinforced Endotracheal Tube with EMG Reinforcement as well as the NIM Standard Reinforced 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 Ventilators

Injuries: 4

Deaths: 1

Medtronic Recalls HVAD Pump Implant Kit

Injuries: 2

Deaths: 1

Medtronic recalls HeartWare HVAD System Batteries

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Medtronic Inc.

Injuries: 55

Deaths: 0

Arrow International, LLC as a Subsidiary of Teleflex Inc., recalls the Arrow-Trerotola PercutaneousThrombolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls the iCast-Covered Stent

Injuries: 9

Deaths: 0

Vyaire Medical Recalls bellavista1000e Series Ventilators

Injuries: 7

Deaths: 0

LivaNova (TandemLife) Recalls LifeSPARC System

Injuries: 2

Deaths: 0

Draeger, Inc Recalls the SafeStar55 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


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