Covidien, LP Recalls Ventilators Due to Manufacturing Assembly Error

Covidien, LP and the US Food and Drug Administration (FDA) announced a recall of Covidien’s Puritan Bennett 980 Series ventilators. The recall focuses on a manufacturing error that can cause the ventilator to malfunction or to stop working. 

Dani Alexis Ryskamp, J.D.

Written by
— Updated on January 18, 2022

Covidien, LP Recalls Ventilators Due to Manufacturing Assembly Error

The Puritan Bennett 980 Series ventilators provide respiratory support to patients who struggle to breathe on their own. Covidien, LP manufactured and distributed these ventilators. Like other types of ventilators, the recalled Covidien ventilators move air in and out of a patient’s lungs. The Covidien ventilators supplement or replace the natural action of the lungs. Ventilators typically have adjustable settings, allowing health care providers to tailor the ventilator’s actions to the patient’s needs.

According to the FDA, the affected Covidien ventilators suffer from a “capacitor manufacturing assembly error.” The error can cause the ventilators to malfunction or to stop working altogether.

When one of the affected ventilators fails in the way the FDA describes, a patient using the ventilator may experience abnormally low blood oxygen levels and/or abnormally high blood carbon dioxide levels. Neurological injury or even death can result.

To date, there were six complaints and one death in relation to issues with the recalled Covidien ventilators.

In a statement from Medtronic, Covidien’s parent company, a patient using an affected ventilator was described as “experienc[ing] cardio-respiratory complications, and pass[ing] away three days later.” In this instance, the ventilator had stopped working while the patient was using it, according to the statement. 

The FDA and Covidien Recalls

The company distributed the affected ventilators between February 23, 2017 and April 4, 2020. The recall affected approximately 135 ventilators in the US, according to the FDA’s recall notice. The recall covers about 278 ventilators worldwide.

Medtronic then notified customers on November 4, 2021 of a potential issue with the recalled ventilators. In the “Urgent Medical Device Correction Letter” Medtronic released, the company asked customers to determine whether they have one of the recalled ventilators. If they do have one of the recalled ventilators, the company advised customers to stop using it. The letter also asked customers to quarantine ventilators until the company could send an engineer to inspect and repair them.

In the same letter, Medtronic also asked customers to notify their own staff. Medtronic asked customers to contact the company with information about affected units and any adverse effects experienced from their use.

In late 2021, Medtronic announced that all of the 135 affected Covidien ventilators in the US had been inspected. Medtronic reported that “no devices were identified as having the reverse capacitor issue.” The company estimated that 94 percent of the ventilators outside the US had been inspected as of December 9, 2021.

Prior Covidien Ventilator Recall Concerns

The Puritan Bennett 980 Series ventilator recall is the third Class I recall Medtronic has faced since 2015. In 2015, the company initiated a recall of over 650 ventilators in the same series due to an error that caused some units to provide less air to patients than health care providers programmed the unit to provide. In 2018, a second recall sought to provide software updates and address user interface issues.

The 2018 recall for software updates followed a suspension imposed by Australia’s Therapeutic Goods Administration (TGA). TGA is part of the country’s Department of Health. Australia’s TGA issued the suspension after receiving several reports that ventilator screens were shutting off. Furthermore, the TGA received reports of either user interfaces not responding or entire ventilator units shutting down or restarting.

“The TGA is concerned that, until rectified, use of these ventilators raises a potential risk of death, serious injury or illness,” the Australian Therapeutic Goods Administration wrote in a September 2017 statement. TGA lifted the suspension in November 2018 after the affected units were examined and the issues addressed.

The FDA lists the Covidien ventilator recall as a Class I recall. Class I recalls are among the FDA’s most serious type of recall. The FDA describes Class I recalls as those “in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

The Covidien ventilator recall comes at a particularly precarious time. Hospitals once again find themselves facing an influx of COVID-19 patients who commonly require breathing support. Injuries or deaths of COVID-19 patients associated with alleged ventilator malfunctions may require the assistance of expert witnesses in pulmonology and related fields to unravel.

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