Recall Weekly
Moderate riskFDA DeviceClass II

Mentor Artoura Breast Tissue Expanders recalled for defective infusion set needles

Mentor Texas, LP is recalling Artoura Breast Tissue Expanders because the infusion sets (the needle and delivery mechanism) may have dull or blunt needle tips. This can make it difficult to insert the needle during the expansion procedure or cause the needle to break.

From the FDA notice · Read the official notice ↗

What to do

  1. If you have had one of these expanders implanted, contact your surgeon or healthcare provider immediately
  2. Do not attempt to use the infusion set if you notice the needle appears dull or does not advance smoothly
  3. Ask your surgeon about replacement infusion sets or alternative expansion approaches
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
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-1685-2026

In the FDA's words

Description
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc, Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. UDI(s): 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504 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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