Recall Weekly
Moderate riskFDA DeviceClass II

Mentor CPX 4 breast tissue expanders recalled for defective infusion set needles

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.

From the FDA notice · Read the official notice ↗

What to do

  1. Contact your surgeon or healthcare provider immediately if you have received this device
  2. Do not attempt to use the infusion set if the needle appears dull or blunt
  3. Ask your provider about replacement options or next steps for your treatment
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
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-1684-2026

In the FDA's words

Description
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 Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. UDI(s):10081317028427 10081317028434 10081317028458 10081317028465 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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