FDA-Device2026-04-08Class IIPROCESSING DEFECT
Mentor Artoura breast tissue expanders recalled for defective infusion needle
What this means
Mentor Texas has recalled Artoura Breast Tissue Expanders because some infusion sets may have dull or blunt needle tips. This can make the needle difficult to insert during the expansion procedure and may cause the needle to break.
- If you have received one of these expanders, contact your surgeon or Mentor Texas immediately
- Do not attempt to use the device if you notice difficulty inserting the needle or any visible damage
- Ask your healthcare provider about next steps, which may include replacement or rescheduling
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: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1687-2026Want us to check the next one for you?
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