Devices

Medtronic Recalls Harmony Delivery Catheter

Medtronic has recalled (Class 1) its Harmony Delivery Catheter due to the potential for a break to occur in the bond holding the capsule at the end of the delivery catheter. The recalled device is part of the company’s Harmony Transcatheter Pulmonary Valve (TPV) System, which is used to treat a leaky native or surgically repaired right ventricular outflow tract (RVOT). It is indicated for use in children and adults who have severe pulmonary regurgitation, which is when blood flows backward from the RVOT into the right lower chamber (right ventricle) of the heart.

If there is a break during a procedure to place the TPV, it could cause procedure delays while the device is replaced with a new one or it may require the patient to undergo additional surgeries, according to a recall notice. “Additionally, a capsule bond break while in use during a procedure could cause serious harm to the patient,” it says. “Those risks include preventing blood flow and/or completely blocking (embolization or occlusion), tearing and/or splitting (perforation or dissection), or other types of damage to the patient’s blood vessels.”

FDA says there have been six reported complaints related to a breakage, including one injury and no deaths.

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