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.

Affected Products

  • Product Names: MEGA Ballast Distal Access Platform (originally cleared as Next Generation Access Platform) 
  • Model and Unique Device Identifier (UDI): 
    • Model No MEGABT09180 (00840303711780)
    • Model No MEGABT09190 (00840303711797)
    • Model No MEGABT091100 (00840303711803)
    • Model No MEGABT091110 (00840303711810)
  • Lot/Serial Numbers: F250600687, F250600686, F250600685, F250600455, F250600346, F250600345, F250600010, F250501434, F250501346, F250501091, F250500824, F250400219, F250400024, F250301020, F250300297, F250100956

What to Do

On September 18, 2025, Balt USA sent all affected customers an Urgent Medical Device Recall notice recommending the following actions: 

  • For hospital staff:
    • 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.
    • Collect and put in quarantine the affected Mega Ballast products, then return them to Balt USA by contacting Balt USA’s Customer Service department.
  • For distributors/subsidiaries:
    • Cease processing of the affected recall product.
    • Inform your customers about this notice.
    • Identify and locate the Mega Ballast products affected by this recall.
    • Collect and put in quarantine the affected Mega Ballast products and return them to your local distributor as per their return procedure.

Reason for Recall

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 represents a manufacturing defect.

The use of 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 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.

Device Use

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 easily bend through tight spaces. It works by following a thin wire guide (guidewire) and uses a dilator tool to help advance through blood vessels, with a special slippery coating on the outer surface (extending 40 cm 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.

Contact Information

Customers in the U.S. with questions about this recall should contact Balt USA Quality Department at 1-949-788-1443 or QA@baltgroup.com.

Additional FDA Resources:

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.