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 as per FDA recalls.

Even though 2022 isn't yet over, the FDA has already put together a list of 50 recalled medical devices. The impact of the recalls so far is a sad 36 deaths and more than 224 injuries. Avanos Medical ranks number one on the 2022 medical device malfunctions list with 23 reported deaths from unintentionally placed feeding tubes.


Avanos Medical The following are the top four hazardous medical device errors, according to the FDA recall notification:

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

Avanos Medical feeding tube This is the most common cause of death for recalled devices.


Avanos Medical has pulled the Cortrak*2 Enteral Access System from service because of the risk of injuries and deaths caused by incorrect placement of nasogastric feed tubes.


Cortrak 2 eternal access system In the event that a nasogastric or nasoenteric tubes is inserted incorrectly, patients could experience injury to the vocal cords, lungs, or trachea, all of which could cause serious injuries or even death. Avanos Medical notified that users "...and hospitals must confirm the location of the N/NI tubes in accordance with hospital protocol. https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Fox News covered the story.

Avanos Medical reported in a recall notification that fatalities and injuries were caused by misplacement or improper use of an tubes for feeding into the enteral system when using the CORTRAK*2 Ental Access System.

Baxter recalls SIGMA Spectrum Infusion Systems, which includes Master Drug Library (Version 8) and Spectrum IQ Infusion Systems (Version 9)
Baxter received 51 cases of serious injury and three reports on patient deaths in the past five years.

Following numerous complaints about safety alarm malfunctions The medical device manufacturer Baxter has decided to recall this device. If there was an upstream obstruction the alarm did not be activated on the pumps. Warnings were made that these products could result in adverse health effects and even death.

Medtronic Recalls NIMCACT Reinforced Endotracheal Tube EMG
This device has been associated with 3 deaths and 2 injuries.

Three injuries and two deaths resulted from the NIMCONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endeotracheal Tube that are used to check laryngeal and head nerves. Even though Medtronic hasn't requested clients to return the damaged devices, it has released safety announcements to try to prevent the cuff made of silicone in the patient's airway.


Cortrak 2 eternal access system Patients can suffer from brain damage, oxygen deprivation or death when the tube does not ventilate effectively or block the airway.

Baxter Healthcare Corporation Recalls Volara System
The device has been linked with 2 injuries and 1 deaths.

Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor on the line to ventilators can prevent patients using the home ventilator from receiving sufficient oxygen. The most vulnerable patients are breathing in mucus and respiratory failure (pneumonia), brain injuries (hypoxia), and choking.


This is the number of lives lost in 2022 as a result of medical device malfunctions or abuse.


Avanos Medical Recalls Cortrak*2 Enteral Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps 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 NIMCONTACT Reinforced Endotracheal Tube that has EMG Reinforcement and the NIM Standard Reinforced Endotracheal Tube

Injuries: 3

Deaths: 2

Baxter Healthcare Corporation Recalls Volara System

Injuries: 1

Deaths: 2

Smiths Medical Remands Certain Medfusion 3500 and 4000 Syringe Pumps

Injuries: 7

Deaths: 1

Medtronic Recalls 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. Recalls HawkOne Directional Atherectomy System

Injuries: 55

Deaths: 0

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

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls ICast, a Stent that is covered by the iCa

Injuries: 9

Deaths: 0

Vyaire Medical Recalls bellavista1000 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


My Website: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding