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Recall Alert: BALT USA Removes MEGA Ballast Distal Access Platform
The FDA is aware that Balt USA is recalling their Mega Ballast Distal Access Platform (originally cleared as Next Generation Access Platform) due to the presence of hydrophilic coating in the inner lumen of the catheter’s distal end. This coating material is not supposed to be inside the device's inner tube and is a manufacturing defect.
The use of the affected products 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 or loss of brain function and death.
As of September 19, 2025, Balt USA has not reported any serious injuries or deaths associated with this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Balt USA Quality Department at 1-949-788-1443 or QA@baltgroup.com.
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