Boston Scientific is recalling approximately 777 IceSeed CX Cryoablation Needles manufactured between April 2024 and February 2025. These needles were incorrectly programmed with demonstration settings instead of commercial settings. While the needles function properly during initial use, the cryoablation system may require the user to repeat integrity testing if the needles are disconnected and reconnected to any channel during a procedure. This issue could potentially cause delays or disruptions during medical treatments, although no injuries or incidents have been reported to date. The needles are specialized medical devices used to apply extreme cold or warmth to tissue.
The demonstration settings on these needles can cause the cryoablation system to prompt for repeated integrity and functionality tests if a needle is disconnected and then reconnected. This unexpected system behavior may lead to delays in surgical procedures or workflow interruptions.
Quantity: 435 units. Intended for use in cryoablation systems to freeze or thaw tissue.
Quantity: 31 units. Intended for use in cryoablation systems to freeze or thaw tissue.
Quantity: 244 units. Intended for use in cryoablation systems to freeze or thaw tissue.
Quantity: 67 units. Intended for use in cryoablation systems to freeze or thaw tissue.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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