Artoura breast tissue expander infusion set needles may be blunt
Mentor Texas is recalling Artoura Breast Tissue Expanders because the infusion sets may contain a dull or blunt needle tip that may be difficult to advance or may break.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a needle that may break or fail to advance during a procedure is a hazard, and no injuries are stated in the source.
Plain-English summary
Mentor Texas, LP. is recalling Artoura Breast Tissue Expanders, smooth high profile, across reference numbers SDC-100H to SDC-155H in sizes from 225 cc to 850 cc. The product was distributed nationwide in the United States and to Canada and more than twenty other countries. The FDA has classified this recall as Class II.
Infusion sets may contain a dull or blunt needle tip, which may be difficult to advance and/or break.
Affected product is listed by UDI in the FDA enforcement record.
Facilities can identify affected expanders by the reference number and UDI, and may contact Mentor Texas, LP. for further information.
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
- Manufacturer
- Mentor Texas, LP.
- Category
- Medical Device — Tissue expander
- Hazard
- needle-defect
- device-breakage
- procedure-risk
Distribution
Distributed nationwide across the United States.
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