Blood clot removal device recalled over safety risk
Penumbra is recalling specific lots of its RED 68 Perfusion Catheter due to an ongoing safety concern.
The U.S. Food and Drug Administration (FDA) has ruled that this is a Class II recall. This means using the device without following the manufacturer’s recommendations could lead to “temporary or medically reversible adverse health consequences.”
The recall was put in place due to a risk of the catheters fracturing. Penumbra has said “manufacturing issues” are to blame, but the company is still investigating the issue to learn more.
What should customers do?
Penumbra is asking customers to review their inventory and quarantine any devices that are part of this recall. The devices should then be returned to the manufacturer. Customers are also being asked to share this information with colleagues as needed.
The RED 68 Perfusion Catheter. Image courtesy of Penumbra.
Boston Scientific recently agreed to acquire Penumbra
Back in January, Boston Scientific agreed to acquire Penumbra for approximately $14.5 billion in a transaction that values the company at $374 per share. That acquisition is expected to close in the months ahead.
“Penumbra is a well-established company with an experienced, high-performing team and this acquisition offers Boston Scientific an opportunity to enter new, fast-growing segments within the vascular space,” Mike Mahoney, chairman and CEO of Boston Scientific, said at the time.
Additional details about the recalled devices
The RED 68 Reperfusion Catheter is used to perform revascularization procedures on patients who present with acute ischemic stroke. It removes blood clots to helps clinicians restore blood flow. The device is 132 cm long and features Penumbra’s REDglide technology.
Penumbra makes several reperfusion catheters, as well as many other medical devices used for different vascular procedures, but this is the only model being recalled.
The catheters included in this Class II recall were distributed throughout the United States as well as Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, the Philippines, Saudi Arabia, Thailand and the United Arab Emirates.
Specific lot numbers included in this Class II recall are H00008699, H00008701, H00008702, H00008703 and C0002003.
Click here for more details from the FDA. Cardiovascular Business has requested additional details from Penumbra. This story will be updated if the company responds.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.