Olympus Takes Action: Safety Concerns Over Single-Use Ligating Device Lead to Voluntary Recall

Olympus Issues Corrective Action for PolyLoop

In a recent announcement, Olympus Corporation has launched a voluntary recall for its Single-Use Ligating Device, known as the PolyLoop. This decision came in light of safety concerns that arose from reports indicating that the device may fail to function correctly during medical procedures.

The PolyLoop is specifically designed to be utilized in conjunction with Olympus endoscopes and serves a critical role in delivering a nylon loop snare for preventing or controlling bleeding after polypectomy procedures, particularly with pedunculated polyps.

Identified Issues

Olympus responded to adverse event reports received from medical professionals which highlighted that the PolyLoop might not always release or detach as intended during usage. Such malfunctions could lead to the loop inadvertently anchoring around the anatomical structures of patients, potentially complicating the procedure and posing significant risks. Despite these alarming findings, Olympus confirmed that there have been no reported fatalities linked to this issue.

However, the implications of an unreleased ligation loop are significant, as they can lead to procedural challenges requiring emergency interventions. Medical personnel may face risks such as bleeding, mucosal injuries, or even perforation of the anatomical sites involved. In severe scenarios, patients could require additional surgical interventions or hospitalization to address complications arising from the device malfunction.

Customer Notifications

In response to the growing concerns, Olympus has proactively communicated with its customers. The company issued a notification letter to all relevant medical facilities in November 2025, urging them to familiarize their staff with the supplemental illustrative guidance and existing warnings associated with the PolyLoop’s usage. The letter also emphasized the importance of understanding the emergency treatment procedures detailed in the device’s Instructions for Use.

Customers located within the United States have been specifically instructed to confirm receipt of the notification through Olympus’s recall web portal. To do this, they need to enter the recall number “0476” for verification.

Reporting Adverse Reactions

In line with their commitment to patient safety, Olympus encourages any adverse reactions or quality issues arising from the use of the PolyLoop to be reported to the FDA's MedWatch program. This program allows for online reporting of serious problems pertaining to medical devices, ensuring that potential risks are tracked and analyzed effectively.

Healthcare providers may access the MedWatch reporting services online through the FDA website. For further assistance or to report existing issues with the PolyLoop, Olympus has made its Technical Assistance Center available, providing support at 1-800-848-9024 or via email.

Conclusion

The corrective action taken by Olympus reflects the company’s dedication to maintaining the highest standards of safety and efficacy in their medical devices. As they navigate these challenges, Olympus remains committed to transparency and providing healthcare professionals with the guidance needed to ensure patient safety. With thorough communication and proactive intervention, Olympus aims to uphold trust and reliability in its products as they address the concerns raised by the PolyLoop's potential safety issues.