Class I — BALT USA, LLC
| Recalling firm | Balt USA, LLC |
|---|---|
| Registered facility | BALT USA, LLC (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen. |
| 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 … |
| Quantity | 207 catheters |
| Distribution | US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT. |
| Initiated | 2025-09-25 |
| Classified | 2025-10-24 |
| Recall number | Z-0188-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — BALT USA, LLC (Z-0188-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97661/
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