Sam Brusco, Associate Editor01.03.22
Medtronic subsidiary Covidien is recalling its Puritan Bennett 980 Series ventilator. The FDA has identified the recall as Class I, meaning using the devices can cause injury or death. Specific model numbers recalled can be found here.
The recall affects Puritan Bennet 980 Series ventilators distributed in the U.S. from February 23, 2017 to April 4, 2020. The firm initiated the recall on November 4, 2021.
135 devices were recalled in the U.S. There have been six complaints regarding the issue, and one death. No injuries have yet been reported.
The reason for recall traces back to a capacitor manufacturing assembly error that has the potential to render the ventilator inoperable, or it may not work as intended. If this happens, the resultant loss of ventilation may cause adverse events like hypercarbia (increase in blood CO2 level), hypoxemia (abnormally low blood oxygen level), neurological injury, or death.
Medtronic advised customers to remove the devices from clinical service and quarantine them until a Medtronic engineer can inspect and replace the affected printed circuit board assemblies.
The recall affects Puritan Bennet 980 Series ventilators distributed in the U.S. from February 23, 2017 to April 4, 2020. The firm initiated the recall on November 4, 2021.
135 devices were recalled in the U.S. There have been six complaints regarding the issue, and one death. No injuries have yet been reported.
The reason for recall traces back to a capacitor manufacturing assembly error that has the potential to render the ventilator inoperable, or it may not work as intended. If this happens, the resultant loss of ventilation may cause adverse events like hypercarbia (increase in blood CO2 level), hypoxemia (abnormally low blood oxygen level), neurological injury, or death.
Medtronic advised customers to remove the devices from clinical service and quarantine them until a Medtronic engineer can inspect and replace the affected printed circuit board assemblies.