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…
Read the official notice →- Date
- 2024-02-14
- Country
- United States
- Brand
- BALT
- Product
- Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under…
- Classification
- Class II
- Units
- U.S.: AZ, CA, CO, FL, GA, HI, IL, KS, MA, ME, MO, MS, NC, NE, NH, NJ, NY, OH,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More BALT recalls
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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
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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 → - 2022-10-26
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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
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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.
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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 →
Other drugs & medical recalls in the United States
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There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic…
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