Mentor Texas, LP is recalling Artoura Breast Tissue Expanders with infusion sets worldwide, including the United States and Canada. The infusion sets may contain dull or blunt needle tips that are difficult to advance or may break. Patients and healthcare providers should stop using the device and follow recall instructions.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Mentor Texas, LP. or your healthcare provider for instructions. Notification method: Letter
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Artoura Breast Tissue Expanders are used in breast reconstruction to gradually create space for implants. They are paired with infusion sets during the procedure.
A dull needle tip in infusion sets can hinder advancement or break, potentially impacting the delivery of therapeutic agents during reconstruction.
This recall is not part of a broader industry pattern.
The recall affects patients undergoing breast reconstruction and may require urgent medical guidance and potential treatment changes.
Recall letter from manufacturer, FDA recall page, device packaging and labeling
Refund or replacement processing typically follows 4-8 weeks after confirmation of eligibility.
Keep copies of the recall letter, model and UDI numbers, purchase records, and all correspondence with the manufacturer and healthcare providers
Model numbers include SDC-100H, SDC-110H, SDC-120H, SDC-130H, SDC-135H, SDC-140H, SDC-150H, SDC-155H. Infusion sets come in sizes 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc. UDI numbers include 10081317028168, 10081317028175, 10081317028199, 10081317028243, 10081317028250, 10081317028267, 10081317028274, 10081317028151. Distribution is worldwide, including US nationwide and the countries of Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia,
No injuries or incidents have been reported.
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