According to the supplier, the recall is due to a manufacturing issue that may make it difficult to remove the microcatheter from its carrier hoop or advance and withdraw it through a guide catheter.
Increased resistance during these processes may damage the device. The affected products are single-lumen, multipurpose microcatheters that healthcare professionals use to access treatment sites in the peripheral vasculature during medical procedures.
The supplier further submitted that the most serious potential harm from a dysfunctional microcatheter is life-threatening embolism, which is assessed as a remote likelihood of occurrence.
The National Consumer Commission (NCC) advised healthcare professionals to immediately discontinue the use of the affected products, remove them from inventory, and segregate them in a secure location pending return to Boston Scientific.
The NCC also advised healthcare professionals to consult the supplier’s recall notice to verify the affected product and lot numbers.
