FDA-Device2026-04-08Class IIPROCESSING DEFECT
Mentor Artoura Breast Tissue Expanders recalled for defective infusion set needles
OTHERNationwide distribution
Stop using Mentor Artoura Breast Tissue Expanders
The infusion sets included with certain Mentor Artoura Breast Tissue Expanders may have dull or blunt needle tips. This defect can make it difficult to insert the needle during the inflation procedure and may cause the needle to break.
- Contact your surgeon or healthcare provider if you have received one of these expanders
- Do not attempt to inflate the expander if you notice difficulty advancing the needle or suspect needle damage
- Ask your provider about a replacement infusion set or device before proceeding with treatment
Hazard
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Sold states
Worldwide distribution - 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, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic.
Manufactured in
3041 Skyway Cir N, Irving, TX, United States
Products
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1686-2026More Mentor Texas, LP. recalls
- FDA-Device2026-04-08Mentor Artoura Breast Tissue Expanders recalled for defective infusion set needles
- FDA-Device2026-04-08Mentor CPX 4 breast tissue expanders recalled for defective infusion set needles
- FDA-Device2026-04-08Mentor CPX 4 breast tissue expanders recalled for defective infusion needle
- FDA-Device2026-04-08Mentor CPX 4 breast tissue expanders recalled for defective infusion set needles
- FDA-Device2026-04-08Mentor CPX 4 breast tissue expanders recalled for defective infusion set needles
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