Devices

Class I Recall of Bolton Medical’s Relay Pro Thoracic Stent Graft System

FDA has classified as Class 1 a Bolton Medical recall of its Relay Pro Thoracic Stent Graft Systems due to reports of a deployment failure that may result in serious injury or death. The company recently issued a device removal notice on specific device configurations, instructing healthcare providers to immediately discontinue use, isolate affected inventory, and return the devices to the manufacturer. The recall affects the Relay Pro Thoracic Stent Graft System N4 non-bare stent configuration devices measuring 32 mm and above.

According to Bolton Medical, the recall was initiated after the company identified cases in which the graft could not be released from the delivery system during a procedure. The failure occurs when the proximal clasp disconnects from the outer control tube, preventing the graft from unclasping from the delivery system.

As of 4/23, Bolton Medical reported three deaths associated with the device issue, according to FDA. These included one death involving aortic perforation, and two deaths following conversion to open surgery, with the patients dying from stroke complications.

The Relay Pro Thoracic Stent Graft System is a minimally invasive device designed to treat damaged or weakened sections of the thoracic aorta, including aneurysms, dissections, and tears. The device is intended to reinforce the vessel wall while maintaining blood flow through placement of a stent graft within the affected area.

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