Irvine, CA, United States
BALT USA, LLC recalls
6 recalls recorded since 2018, most recently on 25 September 2025. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)6
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 25 September 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
Ongoing Class II Medical devices
- Recall started
- 8 May 2025
- Reason
- Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KS, KY, MA, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WI. The countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1989-2025, Z-1988-2025
- Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 008100685
- Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 0
Ongoing Class II Medical devices
- Recall started
- 3 January 2024
- Reason
- Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.
- Distribution
- U.S.: AZ, CA, CO, FL, GA, HI, IL, KS, MA, ME, MO, MS, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, VT, WI and Puerto Rico O.U.S.: Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Ecuador, France, Indonesia, India, Japan, Korea, Malaysia, Mexico, Panama, Paraguay, P
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1041-2024, Z-1042-2024
- Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomal
- The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities
Ongoing Class II Medical devices
- Recall started
- 7 September 2022
- Reason
- Product pouch label does not match up with carton label
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0103-2023
- Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Ongoing Class II Medical devices
- Recall started
- 26 July 2022
- Reason
- Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
- Distribution
- U.S.: AZ and FL O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1680-2022
- Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Ongoing Class II Medical devices
- Recall started
- 4 January 2022
- Reason
- Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure potentially causing some harms like vessel damage, an inability to treat with said device and potential rupture of the aneurysm.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of FL and MD. The countries of Denmark, France, Germany, Lebanon, Netherlands, Sweden, Peru, Portugal, Slovenia, Spain, and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0660-2022
- The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal po
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.