Notes

The most deadly FDA Recalls 2022 - Missing Feeding Tubes Inspiring (Avanos Medical)
As per FDA recalls, the Avanos Medical Cortrak2 is the most hazardous medical device.

The year 2022 isn't to an end, yet the FDA's list of recalled medical devices has already reached 50. Avanos Medical https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its The recalls have resulted in 36 deaths and 224 injuries. Avanos Medical is first on the list of 2022 for malfunctions in medical devices, with 23 reports of deaths due to faulty feeding tubes.


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

Avanos Medical Recalls Cortrak*2 Enteral Access System for feeding tubes
Inadvertently, removing nasogastric feeding tubes resulted in 60 injuries and 23 deaths.

Avanos Medical The malfunction of this device is the biggest cause of death of all medical devices that are recalled by the FDA in 2022..


Avanos Medical has pulled the Cortrak*2 Enteral Access System from service because of accidents and deaths that result from the incorrect placement of nasogastric feed tubes.


Patients could be seriously injured or even death, if a nasal tub or nasoenteric one is wrongly placed. Avanos Medical issued a announcement to the healthcare providers to verify the location of the NG/NI tubing according to institution protocol. https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ Fox news covered the story.

Avanos Medical's recall communications reported that the CORTRAK*2 Enteral Access System was misplaced in enteral feeding tubes since 2015.

Avanos Medical Cortrak 2 eternal access system Baxter recalls SIGMA Spectrum Infusion Systems that include Master Drug Library (Version 8) & Spectrum IQ Infusion Systems (Version 9)
Baxter received 51 cases of serious injury and three reports of patient deaths within the last five years.

Following numerous complaints about malfunctioning safety alarms The medical device manufacturer Baxter has decided to recall this device. Cortrak 2 eternal access system If there was an obstruction upstream the alarm did not activate on the pumps. These products could cause negative health effects that can lead to death, according to the announcement.

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

Three injuries and two deaths resulted from the NIMCONTACT Reinforced EMG Endeotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube both of which are used to check the head and laryngeal nerves. Although the company hasn't asked customers to return defective devices or to replace them, it sent out security alerts to ensure the cuff's silicone material didn't block a patient's airway.


If the tube is unable to adequately ventilate or block the airway, patients can be suffering from oxygen deprivation, brain damage, or death.

Baxter Healthcare Corporation Recalls Volara System
This device has been associated with 2 accidents and one injury. deaths.

Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor on the line to ventilators can prevent patients at-home from getting sufficient oxygen. Cortrak 2 eternal access system The most vulnerable patients are people who breathe mucus or respiratory failure (pneumonia), brain injuries (hypoxia), and the possibility of choking.


This list contains people's lives that were lost because of medical device malfunction or misuse in 2022.


Avanos Medical Recalls Cortrak*2 Enteral Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps (Version 8) & Spectrum IQ Infusion Systems (Version 9) the occlusions

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 the HeartWare HVAD Systems 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 batteries of the HeartWare HVAD system.

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Recall of HawkOne Directional Atherectomy Systems

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 Stents that are covered

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 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


Website: https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its