BALT USA, LLC: Device Recall

Recall #Z-0188-2026 · 09/25/2025

Class I: Dangerous

Recall Details

Recall Number: Z-0188-2026
Classification: Class I
Product Type: Device
Recalling Firm: BALT USA, LLC
Status: Ongoing
Date Initiated: 09/25/2025
Location: Irvine, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 207 catheters

Reason for Recall

Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.

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

Distribution Pattern

US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT.

Other Recalls by BALT USA, LLC

Class II: Risk 05/08/2025

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Class II: Risk 05/08/2025

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

View all recalls by BALT USA, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.