Devices

Abiomed Recalls Impella CP Heart Pumps

Abiomed is recalling (Class 1) certain Impella CP with SmartAssist heart pumps after nine devices in a single lot failed inspection but were inadvertently released to customers. “Using affected pumps may lead to unexpected pump stops or release of potentially harmful particulates,” a recall notice says. “Serious adverse health consequences could result from use of the affected devices, including heart and blood vessel (cardiovascular) complications such as stroke, low blood pressure, damage to red blood cells (hemolysis), bleeding, fluid buildup in the pericardial sac (cardiac tamponade), heart attack (myocardial infarction), the need for additional surgical procedures, or death.” To date, the company says there have been no reported injuries or deaths.

The pumps are used for short-term support of the heart’s pumping chamber (ventricle) during high-risk catheter-based percutaneous coronary interventions. They are indicated for use when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack, open-heart surgery, or when the heart is not optimally functioning (cardiomyopathy).

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