Artoura ultra high profile expander infusion needles may be blunt
Mentor is recalling Artoura Breast Tissue Expanders in the smooth ultra high profile range because the infusion sets may contain a dull or blunt needle tip.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, smooth ultra high profile, reference numbers SDC-100UH, SDC-110UH, SDC-120UH, SDC-130UH, SDC-135UH and SDC-140UH in 350 cc to 850 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 carries UDIs 10081317028182, 10081317028205, 10081317028212, 10081317028229, 10081317028236 and 10081317028281.
Facilities can identify affected expanders by the reference number and UDI above, and may contact the recalling firm for further information.
The recalled product
- Product
- Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
- Manufacturer
- Mentor Texas, LP.
- Category
- Medical Device — Tissue expander
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Mentor Texas, LP. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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