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 Laparoscopic Supra-Cervical Hysterectomy (LSCH).
FDA Recall Z-1978-2019 · Posted None
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Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHEW
Date Initiated2019-06-14
Date Terminated2020-05-19
Product Quantity213 units in total
Reason for Recall
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.
Firm Action
On June 14, 2019, the firm, CooperSurgical, notified customers of the recall via "URGENT: MEDICAL DEVICE RECALL" letters.
Customers were informed that the soft, flexible cup of the Advincula Delineator may crack when subjected to excessive compression during use. The failure mode could lead to serious health consequences such as lacerations.
Customers are asked to do the following;
- Quarantine affected products
- Complete the enclosed Acknowledgement and Receipt form and return to Cooper Surgical via email: [email protected] or fax to
203.601.9870 ATTN: Product Surveillance, even if you do not have affected product.
- Once the firm has received your acknowledgement form, it will arrange for product returns and replacements, if requested.
If you have questions regarding this recall, you may contact the firm at 2036015200 ext. 3300.
Root Cause
Under Investigation by firm
Distribution Pattern
US distribution to state of: AZ, CA, GA, IN, LA, MA, NC, NH, NJ, NY, OH, PA, VA, and WA..
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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