Devices

Datascope Recalls Cardiosave Pumps Over Alarm

Datascope begun an FDA-rated Class 1 recall of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) because of “System Over-Temperature” alarms that require users to power down devices to allow cooling before therapy can be reinitiated. More than 9,000 pumps are affected.

The recall notice says that if the alarm message persists, users should switch to another IABP if available and contact a service representative. “If another IABP console is not available for use, alternative means of providing hemodynamic support (vasopressors, inotropes or alternate therapies) may be initiated by a healthcare provider as a temporizing measure,” it says.

“Consideration should be given to having a backup IABP available in the event the IABP doesn’t cool sufficiently to restart or the alarm reoccurs,” the notice says. “To help prevent such alarms from occurring, ensure that there are no restrictions to the airflow around the Cardiosave device.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome