---
title: "Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Mo... — FDA record Z-0188-2026 | Is It on Recall"
description: "Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen."
url: https://isitonrecall.com/recall/fda-device-z-0188-2026-brand-name-mega-ballast-distal-access-platform-product-name-mega-ballast-model-catalog-number-megabt/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT0... — FDA record Z-0188-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 25, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
- **Classification**: Class I
- **Recalling firm**: BALT USA, LLC
- **Quantity**: 207 catheters
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0188-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0188-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alabama](https://isitonrecall.com/state/alabama/)
- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)

## Dates in the source

- **Report date**: Nov 5, 2025
- **Recall initiation date**: Sep 25, 2025
- **Center classification date**: Oct 24, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0188-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [BALT USA, LLC records](https://isitonrecall.com/brand/balt-usa-llc/)