As per a US Food and Drug Administration (FDA) announcement, Balt USA has removed its Mega Ballast distal access platform from the market due to the presence of hydrophilic coating in the inner lumen of the catheter’s distal end, which represents a manufacturing defect.
The US FDA’s announcement details that, on 18 September this year, Balt USA sent all affected hospital staff an urgent medical device recall notice recommending the following actions: cease use of the affected product; inform all hospital staff members about this recall; identify and locate the Mega Ballast products affected by this recall; and collect and quarantine the affected Mega Ballast products, then return them to Balt USA by contacting the company’s customer service department.
According to the US FDA, the aforementioned coating material “is not supposed to be inside the device’s inner tube”—with the regulator going on to state that use of the affected product may cause serious adverse health consequences, including blood clots that can travel to vital organs, direct damage to blood vessels, blocked blood vessels, blood clot events including stroke, harmful immune system reactions, infections, reduced blood flow to tissues, nerve damage, loss of brain function and death.
While this recall notice has been identified as “the most serious type” by the US FDA, the regulator also details that—as of 19 September 2025—Balt USA has not reported any serious injuries or deaths associated with the issue.
The Mega Ballast 091 is a medical device designed to navigate through curved and winding blood vessels, featuring a semi-rigid back section for stability and a highly flexible front section that can bend through tight spaces. It works by following a thin guidewire and uses a dilator tool to help advancement through blood vessels, with a slippery coating on the outer surface—extending 40cm from the tip—that helps it slide smoothly. The back end has a standard medical connector where other tools can be attached. The device comes sterile, fever-safe, and is designed for single use only.
More information on this medical device recall can be found here.
