FDA Class 1 Recall for Datascope/MAQUET’s Intra-Aortic Balloon Pump

The U.S. FDA has deemed as a Class 1 recall the Datascope Corporation/MAQUET voluntary worldwide field correction, issued in March of certain of the company’s Intra-Aortic Balloon Pumps (IABPs). A potential mechanical failure means the system could shut down, with adverse patient consequences.

Thoratec Says Switches from Older HeartMate EPC System Controller to Pocket Controller Highest Risk

Thoratec has issued updated information regarding the problems highlighted in its device correction letter of two weeks ago. It’s reinforcing the guidance that patients should visit their doctor for retraining on how to use the Heartmate II device in the light of new evidence that the process of changing from older controllers presents the highest risk of problems.

Deaths Prompt Thoratec to Issue Warning on HeartMate II® LVAS

Heart assist device company Thoratec Corporation has initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II® LVAS Pocket System Controller. The advisory follows four deaths among patients while initiating switches of controller.

Mathys Issues Urgent Field Safety Notice for balanSys® Knee System

With total joint implants, one tiny mistake can have significant consequences. In this case no patient injury has been reported, but labelling within the Mathys balanSys Knee system incorrectly matches tibial and femoral components, with the risk of subsequent instability and pain. The company has issued a field safety notice.

Internal Fault Prompts FDA Safety Communication on Philips’ HeartStart Auto Defibrillators

Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the US FDA has said in a new safety communication for users of these previously recalled devices.