Recall Weekly
Moderate riskFDA DeviceClass II

Mentor Artoura breast tissue expanders recalled for defective infusion needle

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.

From the FDA notice · Read the official notice ↗

What to do

  1. If you have received one of these expanders, contact your surgeon or Mentor Texas immediately
  2. Do not attempt to use the device if you notice difficulty inserting the needle or any visible damage
  3. Ask your healthcare provider about next steps, which may include replacement or rescheduling
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

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-1687-2026

In the FDA's words

Description
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 Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281 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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