FDA-Device2026-04-08Class IIPROCESSING DEFECT
Mentor CPX 4 breast tissue expanders recalled for defective infusion needle
What this means
Mentor Texas is recalling certain CPX 4 breast tissue expanders because the infusion sets may have a dull or blunt needle tip. This can make it difficult to insert the needle or cause it to break during use. No injuries have been reported.
- If you received one of these expanders, contact your surgeon or Mentor immediately
- Do not use the infusion set if the needle appears dull or blunt
- Ask your healthcare provider about getting a replacement infusion set
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
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1681-2026Want us to check the next one for you?
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