FDA-Device2026-04-08Class IIPROCESSING DEFECT
Mentor Artoura Breast Tissue Expanders recalled for defective infusion set needles
What this means
Mentor Texas, LP is recalling Artoura Breast Tissue Expanders because the infusion sets (the needle and delivery mechanism) may have dull or blunt needle tips. This can make it difficult to insert the needle during the expansion procedure or cause the needle to break.
- If you have had one of these expanders implanted, contact your surgeon or healthcare provider immediately
- Do not attempt to use the infusion set if you notice the needle appears dull or does not advance smoothly
- Ask your surgeon about replacement infusion sets or alternative expansion approaches
The agency's original wording
Hazard
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Intended for
Adults
Illnesses reported
None reported
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: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1685-2026Want us to check the next one for you?
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