Devices

FDA Issues Alert on Abiomed Impella Controllers

CDRH is issuing an early alert to notify the public about an Abiomed action recommending that all Automated Impella Controllers (AIC) be removed from where they are used or sold. The removal is due to “purge cassette recognition issues resulting from failures of the purge flag component within the purge pressure sensor assembly,” according to an FDA notice. “The purge flag engages with the purge disc and allows the AIC to recognize that the purge disc is inserted properly.”

If the failure occurs before support is started, there may be a delay to the procedure, FDA says. In cases involving hemodynamic instability, this delay may result in a prolonged period without mechanical circulatory support. Abiomed has reported 37 serious injuries and three deaths associated with the issue.

FDA notes that Abiomed is addressing these failures by replacing the purge flag and purge retainer components within the purge pressure sensor assembly of the AIC. Replacements will be made through annual preventative maintenance or individual outreach by Abiomed’s service team.

The Automated Impella Controller is the primary user control interface for the Impella Catheter. It controls the Impella Catheter performance, monitors the catheter for alarms, and provides catheter position information regarding the location of the catheter across the aortic valve.

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

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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