FDAJune 14, 2019device
Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopi...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The soft, flexible cup of the Advincula Delineator may be unvalidated and could potentiall crack when subjected to excessive compressions during use, leading to serious health consequences, such as lacerations.
What to do
FDA enforcement status: Terminated
Brands named
coopersurgical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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