Notes

The most deadly FDA Recalls 2022. Misplaced Feeding Tubes Ahead (Avanos Medical)
As per FDA recalls, Avanos Medical Cortrak2 is the most dangerous medical device.

Even though 2022 isn't yet over but the FDA has already created the following list of recalls of medical devices. Avanos Medical The impact of the recalls to date is a sad 36 deaths and the number of injuries is 224. Avanos Medical ranks first on the 2022 list of malfunctions of medical devices, with 23 reports of deaths caused by misplaced feeding tubes.


Avanos Medical Cortrak 2 eternal access system These are the four deadliest medical device failures as per the FDA medical device recall Notice:

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
Misplacement of nasogastric feed tubes caused 60 injuries and 23 deaths.

Avanos Medical feeding tube This is the most frequent cause of death for recalls of devices.


Avanos Medical has recall the Cortrak*2 Enteral Access System after reports of injuries and deaths from patients who received Nasogastric or Nasoenteric feeding tubes that were improperly placed.


If a nasogastric, or Nasoenteric, tubes are improperly placed, patients could be harmed by their vocal cords, lungs, or trachea. This can cause serious injury and even death. Avanos Medical issued a notification to doctors and other healthcare professionals to confirm the placements of the NG/NI tube per institutional procedure. Fox news published an article about the issue.

Avanos Medical reported in a recall notice that the deaths and injuries resulted from the incorrect placement or misuse of the food tube for enteral use while using the CORTRAK*2 Ental Access System.

Avanos Medical feeding tube 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 about serious injuries and three reports regarding patient deaths possibly related to this concern over the past five years.

Avanos Medical Baxter, a company that makes medical devices , has recalled the device following numerous reports of a safety alarm failure. The alarms on the pumps weren't being activated in case of occlusions in the upstream. It was warned that the items could have negative health effects and could even cause death.

Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube
There have been 3 injuries and 2 deaths associated to the use of this device.

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube - which are used to open an airway and monitor laryngeal nerves during head and neck surgeries - have been the source of three injuries and two deaths in the lead up to Medtronic's recall. The company hasn't asked clients to return or exchange the affected devices but issued safety warnings to keep the device's cuff from blocking the patient's airway.


Patients could suffer from the deprivation of oxygen, brain injuries or even death if the tube isn't ventilated correctly.

Baxter Healthcare Corporation Recalls Volara System
The application of this device led to 2 injuries and 2 deaths.

Avanos Medical feeding tube Avanos Medical feeding tube Baxter Healthcare Corporation, and Hillrom the subsidiary company, are recalling the Volara Systems. The reason for this is that the adaptor that is used to connect in-line ventilators could not allow patients with home use to get enough oxygen. The most vulnerable patients are people who breathe mucus, respiratory failure (pneumonia), brain injury (hypoxia) and choking.


This is the list of human lives lost in 2022 because of medical device malfunctions or abuse.


Avanos Medical Recalls Cortrak*2 Enteral Access System

Injuries: 60

Deaths: 23

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

Injuries: 51

Deaths: 3

Medtronic recalls NIM CONTACT Reinforced Endotracheal Tube and the NIM Standard 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 Pumps for Infusion

Injuries: 7

Deaths: 1

Medtronic recalls HVAD HeartWare system batteries

Injuries: 6

Deaths: 1

Philips Respironics Recalls All V60 and V60 Plus 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, Subsidiary of Teleflex Inc., recalls the Arrow-Trerotola PercutaneousThrombolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls the iCast Stent, which is covered by iCas

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 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


My Website: https://www.raps.org/regulatory-focus™/news-articles/2018/1/fda-warns-doctors-of-collapsed-lungs-and-deaths-possibly-linked-to-feeding-tube-placement-devices