Olympus Corporation has announced a voluntary corrective action for its Single-Use Ligating Device, known as the "Polyloop," after identifying a potential safety issue. The device is used with Olympus endoscopes to deliver a nylon loop snare intended to prevent or control bleeding following the removal of pedunculated polyps.
The company initiated this action in response to reports that the Polyloop may fail to release or detach as expected during procedures. This malfunction can result in the loop becoming unintentionally anchored around patient anatomy. While no deaths have been reported, Olympus stated that an unreleased ligation loop can cause procedural difficulties and may require emergency intervention for removal. Potential risks include bleeding, mucosal injury, perforation, and in severe cases, surgical intervention or hospitalization.
Customers were notified of the corrective action by letter in November 2025. They are advised to ensure all staff are familiar with supplemental illustrative guidance and existing warnings and cautions, including emergency treatment procedures detailed in the product's Instructions for Use. U.S. customers are requested to acknowledge receipt of this notification on the Olympus recall web portal at https://olympusamerica.com/recall using recall number "0476".
Olympus encourages users who experience adverse reactions or quality problems with this product to report them through the FDA’s MedWatch program online at https://www.fda.gov/safety/medwatchfda-safety-information-and-adverse-event-reporting-program/reporting-serious-problemsfda.
For further information or to report issues regarding the device, customers can contact the Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) or email complaints@olympus.com.
