The Recall Desk
SevereFDA (Devices)·Z-1978-2019·Announced 2019-07-24

CooperSurgical Recalls Advincula Delineator Uterine Manipulator Due to Potential Cracking

CooperSurgical is recalling 213 units of the Advincula Delineator Uterine Manipulator because the soft cup may crack during use, posing a risk of lacerations.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the defect could lead to 'serious health consequences, such as lacerations,' which aligns with the rubric criterion for 'significant injury' reports or risks, warranting a Severe (4) classification.

Plain-English summary

CooperSurgical, Inc. is recalling 213 units of the Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm (Part No. AD750SC-KE30), Lot 021-19. This single-use disposable device is designed for Total Laparoscopic Hysterectomy, Laparoscopic Assisted Vaginal Hysterectomy, and Laparoscopic Supra-Cervical Hysterectomy.

The recall is being issued 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 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 providers and facilities should stop using the affected devices and contact CooperSurgical for further instructions.

The recalled product

Product
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)
Manufacturer
CooperSurgical, Inc.
Category
Medical Device — Surgical Instrument
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 021-19

Distribution

Distributed in 14 states:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · CooperSurgical, Inc.

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Same hazard · laceration

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