Reported Nov 5, 2025 · Ongoing
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180,…
Balt USA, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BALT USA, LLC · 29 Parker Ste 100 · Irvine, CA · 92618-1667
Is this the product you have?
- Brand NameMEGA Ballast
- Distal Access Platform Product NameMega
- Ballast Model/Catalog Number
MEGABT09180MEGABT09190MEGABT091100
- MEGABT091110 Software VersionN/A
- Product DescriptionThe 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
- ComponentNot a component
- Lot codes and dates
- Model Numbers and UDI-DI codesModel No MEGABT09180 (00840303711780) Model No MEGABT09190 (00840303711797) Model No MEGABT091100 (00840303711803) Model No MEGABT091110 (00840303711810)
- Lot Numbers
F250600687F250600686F250600685F250600455F250600346F250600345F250600010F250501434F250501346F250501091F250500824F250400219F250400024F250301020F250300297F250100956
- Amount recalled
- 207 catheters
Where it was sold
Why it was recalled
Stop using this product now
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Using this product could cause serious injury, illness or death — stop using it now.
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