Notes

The FDA's most deadly recalls for 2022 - Misplaced Feeding Tubes Leading (Avanos Medical)
According to FDA recalls The Avanos Medical Cortrak2 feeding tube is the most deadly medical device.

While 2022 isn't completed, FDA already has 50 medical devices on the recall list. The recalls have caused 36 deaths and the injury of 224. Avanos Medical is first on the list of 2022 for malfunctions in medical devices, with 23 reported deaths due to misplaced feeding tubes.


Avanos Medical feeding tube The four are the most serious medical device malfunctions, according to the FDA recall notice.

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
Inadvertently removing the nasogastric feeding tube tubes led to 60 injuries and 23 deaths.

This is the leading cause of death among recalls of devices.


Avanos Mediacal Cortrak 2 Avanos Medical has recall the Cortrak*2 Enteral Access System after reports of injuries and deaths in patients who received nasogastric or nasoenteric feeding tubes that were not correctly placed.


If a nasogastric, or nasal, or nasoenteric, tube has been incorrectly installed, patients could be injured to their vocal cords, lungs or trachea. Avanos Medical feeding tube It could result in severe injury and even death. As a precaution, Avanos Medical sent notice to providers and suggested that the user or the hospital "...confirm the position of the NG/NI tubes in accordance with hospital protocol" Fox news reported.

Avanos Medical's recall communication stated the deaths and injuries that resulted from the misplacement the tubes feeding into the enteral lining in the CORTRAK* 2 Enteral Access System as of 2015.

Baxter recalls SIGMA Spectrum Infusion Systems with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems (Version 9)
Baxter has received 51 complaints of serious injuries as well as three cases of deaths in the past five years that could be associated with this issue.

The medical device manufacturer Baxter recalls this device after numerous complaints of a safety alarm malfunction. Avanos Medical The alarms on the pumps weren't being activated in case of occlusions in the upstream. These substances can have adverse health effects , which could lead to death according to the announcement.

Medtronic Recalls NIMCACT Reforced EMG Endotracheal Tub
There have been 3 incidents of injury and two deaths by the use of this device.

Three injuries and two deaths were caused by the NIMCONTACT Reinforced EMG Endotracheal Tube as well as the NIM Standard Reinforced EMG Endotracheal Tube that serve to monitor laryngeal and head nerves. Although Medtronic isn't asking for its customers to return their damaged devices, it has released safety announcements to help prevent the cuff made of silicone from blocking the airway of a patient.


Patients are at risk of suffering from oxygen deprivation, brain damage or even death if the tube doesn't ventilate well or blocks the airway.

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

Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System due to the fact that the inline ventilator adaptor may prevent home-use patients not getting enough oxygen through their ventilators. The most vulnerable patients are breathing in mucus respiratory failure (pneumonia) and brain injury (hypoxia) and the possibility of choking.


This is a listing of people's lives that were lost because of medical device malfunction or misuse in 2022.


Avanos Medical Recalls Cortrak*2 Ental 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 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 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 the HVAD Pump Implant 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. Avanos Medical feeding tube Medtronic Inc.

Injuries: 55

Deaths: 0

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

Injuries: 14

Deaths: 0

Atrium Medical Corporation recalls iCast that covered sten

Injuries: 9

Deaths: 0

Vyaire Medical Recalls bellavista 1000 Series 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


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