Recall Weekly
Moderate riskFDA DeviceClass II

Mentor Artoura Breast Tissue Expanders recalled for defective infusion set needles

The infusion sets included with certain Mentor Artoura Breast Tissue Expanders may have dull or blunt needle tips. This defect can make it difficult to insert the needle during the inflation procedure and may cause the needle to break.

From the FDA notice · Read the official notice ↗

What to do

  1. Contact your surgeon or healthcare provider if you have received one of these expanders
  2. Do not attempt to inflate the expander if you notice difficulty advancing the needle or suspect needle damage
  3. Ask your provider about a replacement infusion set or device before proceeding with treatment
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 7 products — see all of them.

Details

Illnesses reported
None reported
Manufactured in
3041 Skyway Cir N, Irving, TX, United States
Classification
Class II
Recall number
Z-1686-2026

In the FDA's words

Description
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. UDI(s): 10081317028168 10081317028175 10081317028199 10081317028243 10081317028250 10081317028267 10081317028274 10081317028151 Distribution: 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.
Hazard
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

7 products in this recall

Mentor breast tissue expanders recalled for dull needle tip risk

Mentor is recalling 7 product lines of breast tissue expanders, including CPX 4 US and Artoura models. The recall notice says the needle tip may be dull or blunt, which could make it hard to advance or cause it to break. No injuries have been reported. The notice refers to infusion sets, while the listed products are tissue expanders, so check the notice for details.

The agency lists each product separately. Check every one you might have.

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