FDA Recalls Advincula Delineator Uterine Manipulator Due to Cracking Risk
CooperSurgical is recalling 213 units of the Advincula Delineator Uterine Manipulator because the soft cup may crack during use, posing a risk of lacerations.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and the source text explicitly states the defect could lead to 'serious health consequences, such as lacerations,' which aligns with the rubric criteria for a Severe rating involving significant injury reports or risks.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Advincula Delineator Uterine Manipulator, manufactured by CooperSurgical, Inc. The specific product affected is the Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm, Part No. AD750SC-KE25, Lot 017-19. A total of 213 units are involved in this recall.
The recall is being conducted because the soft, flexible cup of the device may be unvalidated and could potentially crack when subjected to excessive compressions during use. This defect could lead to serious health consequences, such as lacerations. The device is a single-use disposable instrument designed for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH).
The affected units were distributed in the United States to the states of Arizona, California, Georgia, Indiana, Louisiana, Massachusetts, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Virginia, and Washington. Healthcare facilities and providers who have received this product should stop using it immediately and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy…
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 213
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 017-19
Distribution
Part of a larger recall action
This product is one of 2 recalled by CooperSurgical, Inc. 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.
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