Artoura textured tissue expander infusion set needles may be blunt
Mentor is recalling textured Artoura Breast Tissue Expanders with integral injection dome because the infusion sets may contain a dull or blunt needle tip.
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
Artoura Breast Tissue Expanders, textured, high and ultra high profile with integral injection dome, reference numbers TEXP110RH, TEXP120RH, TEXP120RUH, TEXP130RH, TEXP135RH, TEXP140RH and TEXP150RH in 300 cc to 750 cc, are being recalled. 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 reference number and UDI in the FDA enforcement record.
Facilities can identify affected expanders by the reference number above, and may contact the recalling firm for further information.
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,
- 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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