Recall Weekly
Moderate riskFDA DeviceClass II

Mentor CPX 4 breast tissue expanders recalled for defective infusion needle

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.

From the FDA notice · Read the official notice ↗

What to do

  1. If you received one of these expanders, contact your surgeon or Mentor immediately
  2. Do not use the infusion set if the needle appears dull or blunt
  3. Ask your healthcare provider about getting a replacement infusion set
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: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
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-1681-2026

In the FDA's words

Description
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) Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. 00081317006671 00081317006794 00081317006800 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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