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 breast tissue expanders
Mentor Texas breast tissue expanders used in reconstruction surgery may have infusion sets with dull or blunt needle tips. These needles may be difficult to insert during the expansion process and could break inside the device. No injuries have been reported.
- Contact your surgeon or healthcare provider immediately if you have received this device
- Do not attempt to use the infusion set if the needle appears dull or blunt
- Ask your provider about replacement options or next steps for your 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
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1684-2026More 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 needle
- FDA-Device2026-04-08Mentor CPX 4 breast tissue expanders recalled for defective infusion set needles
- 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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