FDA-Device2026-04-08Class IIPROCESSING DEFECT
Mentor CPX 4 breast tissue expanders recalled for defective infusion set needles
OTHERNationwide distribution
Stop using Mentor CPX 4 tissue expanders
Mentor Texas has recalled CPX 4 US Breast Tissue Expanders because some infusion sets may have dull or blunt needle tips. These dull needles can be hard to insert and may break during use. No injuries have been reported.
- If you received this device, contact your surgeon or Mentor immediately
- Do not use the infusion set if the needle appears dull or damaged
- Ask your healthcare provider about replacement or alternatives
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
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1682-2026More 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 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
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