Mentor Texas, LP. has recalled various models of CPX 4 US and Artoura Breast Tissue Expanders because the included infusion sets may contain dull or blunt needle tips. These needles may be difficult to advance through the skin or could potentially break during use. The recall affects several styles including SILTEX, Smooth, High Profile, and Ultra High Profile expanders manufactured in the United States and distributed worldwide.
A dull or blunt needle can make it difficult for healthcare providers to perform necessary injections into the device, and a needle that breaks during a procedure could leave fragments in the patient or cause internal injury. While the device itself is an implant, the failure occurs during the expansion process which is critical for tissue preparation.
Correction or return of affected infusion sets
Recall #: Z-1681-2026
Recall #: Z-1682-2026
Recall #: Z-1683-2026
Recall #: Z-1684-2026
Recall #: Z-1685-2026
Recall #: Z-1686-2026
Recall #: Z-1687-2026
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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