Boston Scientific Corporation is recalling approximately 3,010 units of TENACIO Pumps and related preconnected inflatable penile prosthesis systems (CX, LGX, and CXR models). The recall is being issued because these devices may experience performance issues involving the inability to properly inflate or deflate. Affected products were distributed nationwide in the United States and in Canada. Consumers should contact their healthcare provider if they have these implants and experience any difficulties with function.
The device may fail to inflate or deflate as intended, which can prevent the product from functioning correctly for the patient. A malfunction may require medical intervention or surgical replacement of the implanted device to restore function.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.