BALT USA, LLC recalls
Every recall we track for BALT USA, LLC — 8 in all, from 2022–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
8 recalls since 2017.
All FDA recall records for BALT USA, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 1 | 1 | 1 | 3 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 2 | 0 | 2 |
| 2025 | 0 | 1 | 1 | 1 | 3 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled BALT USA, LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All BALT USA, LLC recalls
6 shown- Use cautionMedical device
BALT USA, LLC recalls Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180,
U.S. recall of Mega Ballast catheters (models MEGABT09180-091110) due to coating lifting in distal lumen. Stop using if you own these models.
MEGA BallastSep 25, 2025 - UnratedMedical device
BALT USA, LLC recalls Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT
BALT USA recalls Prestige Coil System models with specific REFs/UDI-DI codes due to radiopaque marker not being visible during angiography, potentially affecting medical procedures.
BALT USAMay 8, 2025 - Lower riskMedical device
BALT USA, LLC recalls Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the
BALT USA recalls Optima Coil System devices due to discoloration from corrosion on delivery pusher components, which could break off and cause foreign emboli in patient vasculature. Affected models include Optima Coils 1mm x 1cm, 1mm x 2cm, and others with specific model numbers and lot numbers listed in the recall.
BALT USAJan 3, 2024 - Lower riskMedical device
BALT USA, LLC recalls Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
BALT USA recalls Optima Coil System models OPTI0208CSS10 and OPTI0308CSS10 due to pouch label not matching carton labels. This mismatch may cause confusion during medical procedures.
BALTSep 7, 2022 - UnratedMedical device
BALT USA, LLC recalls Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
BALT USA recalls Optima Coil System Model OPTI0520CSF10 for endovascular embolization due to release before test report approval from alternate supplier.
BALT USAJul 26, 2022 - Use cautionMedical device
BALT USA, LLC recalls The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to
BALT USA recalls Optima Coil System due to incorrect labeling potentially causing wrong coil size selection during procedures, risking vessel damage or aneurysm rupture. Affected units have specific model and lot numbers.
BALT USAJan 4, 2022
BALT USA, LLC recall questions
How many recalls has BALT USA, LLC had?
8 recalls from BALT USA, LLC are on record with U.S. safety agencies, from 2022–2025.
What is the most recent BALT USA, LLC recall?
BALT USA, LLC recalls Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180,, dated Sep 25, 2025. Every BALT USA, LLC recall is listed on this page, newest first.
What should I do if I have a recalled BALT USA, LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new BALT USA, LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.