# FDA recall Z-0188-2026

> **BALT USA, LLC** · Class I · device recall initiated 2025-09-25.

## 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

## 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.

## Key facts

- **Recall number:** Z-0188-2026
- **Recalling firm:** BALT USA, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-25
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0188-2026

## Citation

> AI Analytics. FDA recall Z-0188-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0188-2026. Source: US FDA. Licensed CC0.

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