Categories

LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure

The LifeSPARC System is being recalled for risk that users can inadvertently cause extended pump stop when replacing the controller after software malfunction.

http://www.fda.gov/medical-devices/medical-device-recalls/livanova-tandemlife-recalls-lifesparc-system-risk-unintentional-extended-pump-stop-during-controller

 
Categories

LivaNova (TandemLife) Adds Software Update to Recall for LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure

The LifeSPARC System is being recalled because users can inadvertently cause extended pump stop. A software update will address this issue.

http://www.fda.gov/medical-devices/medical-device-recalls/livanova-tandemlife-adds-software-update-recall-lifesparc-system-risk-unintentional-extended-pump

 
Categories

LivaNova (TandemLife) Adds to Recall for LifeSPARC System that May Experience Unintentional Extended Pump Stops Due to Controller Critical Failure

The LifeSPARC System is being recalled because users can inadvertently cause extended pump stop. A software update will address this issue.

http://www.fda.gov/medical-devices/medical-device-recalls/livanova-tandemlife-adds-recall-lifesparc-system-may-experience-unintentional-extended-pump-stops

 
Categories

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward
http://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol

 
Categories

Datascope/Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk That Blood May Enter Pump Through Damaged Balloon Catheter, Causing Patient Harm

Blood may enter the Cardiosave IABP through a damaged balloon catheter, causing pump shut-down, or patient exposure to helium or cross-contaminated blood

http://www.fda.gov/medical-devices/medical-device-recalls/datascopegetinge-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabp-risk-blood-may