On December 3, 2025, the FDA announced a significant correction related to Olympus’s Single Use Ligating Device PolyLoop. This update is particularly relevant for clinical, quality, and regulatory teams who rely on the device for controlling bleeding after polypectomy procedures.
Affected Device and Reason for Update
The recall pertains to updated instructions for the proper use of the Single Use Ligating Device PolyLoop (Model HX-400U-30), which was manufactured between September 22, 2022, and September 7, 2025. Olympus’s investigation revealed that the ligation loop in some devices failed to release or detach as expected during use. This issue led to the loop unintentionally anchoring around patient anatomy, creating risks such as procedural delays and severe injuries.
Olympus reported 113 serious injury complaints linked to this problem but noted no deaths as of October 1, 2025. The FDA classified this announcement as the highest-risk category, underscoring the potential consequences of continuing to use the device without adhering to updated guidelines.
Key Updates to Device Use
To mitigate risks and ensure proper functionality, Olympus issued specific recommendations to users:
- Read all updated guidance and warning statements in the instructions for use carefully.
- Always have Olympus’s loop cutter available when using the PolyLoop device for emergency removal if needed.
- When operating the yellow tube joint (referred to as the yellow cylinder), avoid moving it away from the handle prematurely as this could tighten the loop and prevent its release.
- If resistance occurs while advancing the slider located on the device handle, stop immediately. Forcing the slider could render the ligation loop unable to release.
- Ensure the proximal end of the tube sheath remains straight during use. This prevents increased friction, which may cause breakage and create removal complications.
The manufacturer emphasized that these updated practices are essential for the safe use of the device and advised healthcare professionals to avoid any techniques not outlined in the instructions, unless emergency equipment is unavailable or fails.
Actions for Customers
Olympus has requested that customers acknowledge receipt of the correction notice through the company’s recall web portal. Affected customers can follow these steps:
- Visit https://olympusamerica.com/recall.
- Enter the recall number 0476.
- Complete the required acknowledgment form.
- If further distribution of the product occurred, identify downstream customers and share the notification with them.
Healthcare professionals with questions about the recall are advised to contact Olympus at 1-800-848-9024, selecting option 1.
Risks and Emergency Intervention
Failure to follow updated instructions could lead to serious complications, including severe tissue injuries, bleeding requiring transfusion, perforation, prolonged procedural delays, or hospitalization. Olympus has provided guidance for safe emergency removal methods. When removal is necessary, the risks are generally minimized if standard techniques (e.g., the loop cutter) outlined in section 12 of the product instructions are successfully implemented.
In instances where standard methods fail or are not attempted, alternative techniques—specifically those not recommended by Olympus—may escalate risks and increase severity of outcomes.
What is the PolyLoop Device?
The Olympus Single Use Ligating Device PolyLoop is designed for use with an Olympus endoscope. It delivers a nylon loop snare to control or prevent bleeding after polypectomy procedures involving pedunculated polyps.
Its intended purpose is to aid clinicians in achieving hemostasis during endoscopic treatments while maintaining patient safety. Adherence to the specified instructions is critical to ensuring the device performs as intended.
Conclusion
Users of the Single Use Ligating Device PolyLoop should prioritize reviewing Olympus’s updated guidelines to prevent device-related complications. Acknowledging the recall through Olympus’s portal and implementing the recommended precautions is essential for maintaining patient safety and procedural efficacy.
Disclaimer
This post serves as a professional informational summary and is not intended as legal advice. Healthcare professionals should consult official documentation and regulatory authorities when evaluating actions related to this announcement.
Mandatory FDA Information
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/correction-alert-olympus-updates-use-instructions-ligating-device