Over One Million Angiographic Catheters Recalled from Hospitals

A typical treatment to find obstructions in blood arteries is a coronary angiography procedure, which involves inserting a thin tube called catheters into an artery in typically the arm or leg and guiding them to the heart.

The Expo 5Fr Angiographic Catheters, which are utilised in percutaneous coronary intervention treatments as diagnostic tools, are among the withdrawn equipment.

“Our internal investigation identified evidence of the inner polymer layer of the catheter separating from other layers and, in some instances, this material detaching inside the device,” Stated the Boston Scientific.

The recall was classified as a Class I occurrence by the FDA, which is the highest level of severity.

As stated in Boston Scientific’s March notice to medical providers, hospitals were advised to separate and stop using any recalled goods that were in their possession. The nonprofit organisation ECRI, which is concerned with the security of patients, sent this message to MedTech Dive.

Boston Scientific stated in the message that it has not heard of anyone suffering injuries as a result of the issue. Nonetheless, the business stated that while improbable, major negative health effects could occur such as myocardial infarction or a stroke.