BALT recalls
6 official recalls and safety alerts involving BALT since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with BALT or the relevant agency.
- 2025-11-05
USBALT USA, LLC recalls Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100,…
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
FDA · DeviceBALT USA, LLCUS distribution to states of: AL, CA, CO, CT, FL, IL, KY, MA, NY, TN, TX, and…Official notice →- 2025-06-25
- US
BALT USA, LLC recalls Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694…
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
FDA · DeviceBALT USA, LLCWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice → - 2024-02-14
- US
BALT USA, LLC recalls Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under…
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…
FDA · DeviceBALT USA, LLCU.S.: AZ, CA, CO, FL, GA, HI, IL, KS, MA, ME, MO, MS, NC, NE, NH, NJ, NY, OH,…Official notice → - 2022-10-26
- US
BALT USA, LLC recalls Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Product pouch label does not match up with carton label
FDA · DeviceBALT USA, LLCWorldwide distribution - U.S. Nationwide distribution in the states of FL, GA,…Official notice → - 2022-09-14
- US
BALT USA, LLC recalls Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
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.
- 2022-03-02
- US
BALT USA, LLC recalls The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal…
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…
FDA · DeviceBALT USA, LLCWorldwide distribution - U.S. Nationwide distribution in the states of FL and…Official notice →