Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09
Summary
The FDA issued a Class I for Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Mod by BALT USA, LLC. Reason: Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen..
Details
Source
Device Recall
External ID
Z-0188-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Model Numbers and UDI-DI codes: Model No MEGABT09180 (00840303711780) Model No MEGABT09190 (00840303711797) Model No MEGABT091100 (00840303711803) Model No MEGABT091110 (00840303711810) Lot Numbers: F250600687, F250600686, F250600685, F250600455, F250600346, F250600345, F250600010, F250501434, F250501346, F250501091, F250500824, F250400219, F250400024, F250301020, F250300297, F250100956
Quantity Affected: 207 catheters
Reason for Recall
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Distribution
US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-25
Company
Irvine, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 284 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BALT USA, LLC has 20 FDA actions in our database, including 8 recalls and 12 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BALT USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BALT USA, LLC have FDA actions?
BALT USA, LLC has 20 FDA actions in our database, including 8 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0188-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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