The U.S. Food and Drug Administration (FDA) has announced a Class I recall for a series of ventilators belonging to Covidien LP, a subsidiary of device manufacturer Medtronic. The recall was announced after several complaints and one death were reported.
According to the recall announcement on January 3, the Puritan Bennett 980 Series Ventilator from Covidien has a capacitor manufacturing assembly error that can cause the devices to stop working as intended and become inoperable.
When this happens, the FDA reports that patients can suffer from increases in carbon dioxide in the bloodstream (hypercarbia) and abnormally low oxygen levels in the blood (hypoxemia). These complications can lead to neurological injury and, if left unchecked, death.
Due to the serious nature of the potential injuries, the FDA has issued a Class I recall. Class I recalls are reserved for devices whose use could result in serious injury or death. The FDA has also noted that there have been no reported injuries while using the recalled device.
These devices were distributed from February 23, 2017 to April 4, 2020, and the FDA estimates that there are only 135 affected devices remaining in the U.S. The FDA began a dialogue with Covidien late last year in a series of communications that were not yet released to the public.
According to the now-public database logs, on December 9, 2021, the FDA created a recall investigation to address the then 278 Puritan Bennett 980 Series Ventilators in circulation commercially.
According to these database entries, while the stated manufacturer’s cause for the recall is the manufacturing error mentioned in the official recall, the FDA’s stated cause is a failure in reprocessing controls, a process by which a medical device is cleaned, tested, and prepared for reuse.
While the FDA notes that these devices were distributed nationwide, they do not mention any joint operations with other nations’ health departments to ensure that these faulty products are removed from circulation. Rather, the FDA simply focuses on actions to be taken within the U.S., including notifying purchasers of the recall and requiring discontinued use of the devices.