Angiographic catheters recalled due to safety risk
Cook Medical, an Indiana-based medtech company, is recalling certain angiographic catheters due to an increased risk of the tip becoming separated from the rest of the device during treatment.
The U.S. Food and Drug Administration (FDA) has ruled that this is a Class I recall, meaning the continued use of these catheters could result in severe adverse health consequences, including death.
This recall includes nearly 27,000 Cook Beacon Tip 5.0 Fr Angiographic Catheters. The devices are used for various angiographic procedures performed by interventional cardiologists in the cath lab and interventional radiologists.
Customers were first alerted about this issue in May in a notice that emphasized the significant safety issues associated with tip separation. They were instructed to immediately examine their inventory and quarantine any affected products that remain unused. All affected devices can be returned to Cook Medical. In addition, any adverse events associated with these devices should immediately be reported to the company. Reports can also be filed with the FDA.
Click here for more details from the FDA, including the lot numbers associated with this recall and full contact information for Cook Medical.
Cardiovascular Business reached out to Cook Medical for comment but has not yet received an answer. This article will be updated if the company provides any additional statements on the ongoing situation.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.