Recall - Olympus (Single use ligating device) produced by Olympus Corporation - PolyLoop device may fail to detach as expected and become anchored to patient anatomy

Summary

Company Announcement

Center Valley, Pa., (December 5, 2025)-Olympus Corporation today announced a voluntary medical device corrective action for its Single-Use Ligating Device ("Polyloop") following identification of a potential safety issue.

The Polyloop device is designed for use with Olympus endoscopes to deliver a nylon loop snare intended to prevent or control bleeding following polypectomy of pedunculated polyps.

Olympus took this action after receiving adverse event reports indicating that the Polyloop may fail to release or detach as expected during use, resulting in the loop becoming unintentionally anchored around patient anatomy. No deaths have been reported.

An unreleased ligation loop can present procedural challenges, requiring emergency intervention for removal from patient's anatomy. Risks include bleeding, mucosal injury, perforation, and in severe cases, the need for surgical intervention or hospitalization.

Customers were notified of the corrective action by letter in November 2025 and are asked to ensure all personnel are familiar with the supplemental illustrative guidance and existing warnings and cautions, including the emergency treatment procedure outlined in the Instructions for Use. Customers in the U.S. are asked to acknowledge receipt of the letter on the Olympus recall web portal by visiting: https://olympusamerica.com/recall and entering the recall number "0476".

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch program online: https://www.fda.gov/safety/medwatch­fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems­fda.

For information or to report a problem about the device, please contact the Olympus Technical Assistance Center at 1-800-848-9024, Option 1 or email [email protected].