Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Recalled by BALT USA, LLC Due to Due to an identified manufacturing defect involving coating...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BALT USA, LLC directly.
Affected Products
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophilic coating to facilitate lubricity from tip to 40 cm proximal. The proximal end of the Mega Ballast incorporates a Luer fitting hub for the attachment of accessories. The Mega Ballast is provided sterile, non-pyrogenic, and is intended for single use only. Component: Not a component
Quantity: 207 catheters
Why Was This Recalled?
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Where Was This Sold?
This product was distributed to 12 states: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, UT
About BALT USA, LLC
BALT USA, LLC has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report