FDA Medical devices recall ·
MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0188-2026
- Date
- (initiated September 25, 2025)
- Company / brand
- Balt USA, LLC
29 Parker Ste 100, Irvine, CA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 207 catheters
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT.
States: Alabama California Colorado Connecticut Florida Illinois Kentucky Massachusetts New York Tennessee Texas Utah
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0188-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.