Devices

Arrow Intra-Aortic Balloon Pump Recall is Class 1

FDA says the Arrow International 10/17/22 recall of 2,132 intra-aortic balloon pumps is Class 1. An agency statement says the pumps are cardiac assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure.

The company recalled the pumps after receiving complaints that battery power is not lasting as long as expected, FDA says. While a fully charged battery should last 90 minutes, it says, multiple users have reported shorter run times. The notice says the device’s battery life warnings also are inaccurate as the battery depletes more rapidly than indicated.

“If the pump’s battery depletes, the pump may stop when operated on battery power only,” FDA says. “Sudden stopping of the pump’s mechanical support to the patient’s heart can lead to cardiac arrest, stroke, or death.”

FDA says there have been 241 complaints, with 135 reported pump stops. No deaths were reported related to the issue, it says.

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