TAS Medical Inc is recalling approximately 114 Tissue Approximation Systems (TAS), including models T-4000, T-5000, and T-LAP, because the internal zip-tie straps can break before or during implantation. While no injuries have been reported to date, broken straps that are not noticed during a surgical procedure could lead to the recurrence of a hernia or require a second surgery to fix a large herniation. The manufacturer has developed an interim method to rehydrate the straps using a warm saline solution, but users should contact the firm for full instructions.
The zip-tie straps may become brittle and break during use, potentially causing the surgical repair to fail. If a break goes undetected during the procedure, it could result in the patient's hernia returning or requiring additional revision surgery.
Firm developed an interim conditioning method using sterile saline to rehydrate straps.
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.