CooperSurgical recalls Advincula Delineator uterine manipulators with Ultem Plastic Soft Cup size 2.5 cm (Part No. AD750SC-KE25) due to potential cracking during use, which could cause lacerations. Affected units were sold starting Lot 017-19.
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.
CooperSurgical is recalling Advincula Delineator uterine manipulators with a specific soft cup size because the plastic cup might crack under pressure during use, risking lacerations. This is a serious hazard for patients undergoing certain surgeries.
The soft plastic cup in the device may crack when subjected to strong compressions during surgery. This cracking could cause cuts or lacerations to the patient's internal tissues, leading to serious health complications.
Women who have undergone total laparoscopic hysterectomy (TLH), laparoscopic assisted vaginal hysterectomy (LAVH), or laparoscopic supracervical hysterectomy (LSCH) using this specific device are affected. Patients using the recalled model are at highest risk.
Check for the product name 'Advincula Delineator' with Ultem Plastic Soft Cup size 2.5 cm. The part number is AD750SC-KE25. Units were sold starting with Lot 017-19.
Immediately stop using the Advincula Delineator device if you have the recalled model with the specific soft cup size.
The soft plastic cup may crack under pressure during use, which could cause lacerations and serious health consequences.
The part number is AD750SC-KE25 for the Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm.
Look for the product name 'Advincula Delineator' with Ultem Plastic Soft Cup size 2.5 cm and part number AD750SC-KE25. Units were sold starting with Lot 017-19.
We’ve drafted a message you can send CooperSurgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1977-2019 — CooperSurgical CooperSurgical Hello, I own a CooperSurgical that is covered by recall Z-1977-2019 from CooperSurgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
