The U.S. Food and Drug Administration (FDA) announced the following device recalls:

Baxter Volara System

Baxter Healthcare Corporation, and its subsidiary company Hillrom, are recalling the Volara system because the in-line ventilator adaptor may prevent home-use patients from getting enough oxygen from their ventilators. The risks to affected patients include choking on mucus or other airway secretions; pneumonia and respiratory failure; brain injury due to hypoxia; and death. The risk of serious injury or death is more significant in home-care settings if the caregivers are not trained properly, the device is not connected properly, or if the caregiver is not prepared to address any issues that may arise caused by use of this device. There has been 1 injury and 2 deaths associated with the use of this device. More information.

Medtronic HeartWare HVAD System Batteries

Medtronic Inc. is recalling a single lot of HeartWare HVAD System batteries due to welding defects that allow separation of the 2 cell battery packs used to power the system. The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging. As a result, the battery may fail suddenly. If this malfunction occurs, it will trigger a Power Disconnect alarm on the controller screen and in the Alarm Log tab of the HVAD Monitor while the affected battery is still connected to the controller. These alarms may temporarily resolve, but the battery will continue to fail. The use of these batteries may lead to device malfunction, death, or serious injury. Medtronic reports 1 death associated with this recall, and 2 complaints in the affected lot. More information.