FDA Device recall Z-0188-2026
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, ME…
- FDA Device
- Class I
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class I recall of Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, ME… by Balt Usa, citing due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0188-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-09-25 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Balt Usa |
| Distribution | AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, UT |
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.
Identifiers
| code_info | Model Numbers and UDI-DI codes: Model No MEGABT09180 (00840303711780) Model No MEGABT09190 (00840303711797) Model No ME…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0188-2026%22
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