Covidien Recalls Puritan 980 Ventilators
Recall Designated Class 1 by FDA
According to MassDevice, the U.S. Food and Drug Administration (FDA) has designated the recall as a Class 1 recall meaning there is “a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The issue lies in a programming glitch present in ventilators which can cause the device to fail after the ventilator’s air and oxygen supplies are detached and then reattached. The failure can result in death if the patient is not attached to another ventilator or other form of breathing support.
The recall covers all devices manufactured between March 3 and August 19 and distributed until August 22. Covidien recalled their Puritan Bennett 840 earlier this year, also for a software issue.
Additional Recall Information
- The ventilators are used to provide constant breathing support for adults, children, and premature infants that weigh at least 10.6 ounces.
- Problem ventilators are running software versions below 2.8.
- Users of the Puritan Bennett 840 are urged to keep a close eye on their systems and keep another form of breathing support nearby.