Food, drugs, devices › BALT USA, LLC
Device recall: Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT0919
BALT USA, LLC (Irvine, CA) initiated this device recall on 25 Sep 2025; FDA lists 1 product record under event 97661, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 13% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. BALT USA, LLC has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
BALT USA, LLC, Irvine, CA.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0188-2026 | 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… | 207 catheters | Class I | Ongoing | 5 Nov 2025 |
Context
Other enforcement events for BALT USA, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 May 2025 | Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 O | Device | Class II | 2 |
| 3 Jan 2024 | Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vascu | Device | Class II | 2 |
| 7 Sep 2022 | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures. | Device | Class II | 1 |
| 26 Jul 2022 | Optima Coil System Model OPTI0520CSF10. For endovascular embolization. | Device | Class II | 1 |
| 4 Jan 2022 | The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a | Device | Class II | 1 |
All 6 events for BALT USA, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and UT."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.