Olympus PolyLoop Endoscope Ligation Device Linked to More Than 100 Injuries: FDA

Manufacturer is issuing updated instructions for certain PolyLoop ligating devices, warning that they may fail to work as intended.

Medical device manufacturer Olympus warns that its PolyLoop ligation device may not release as intended, which can cause the loop to become stuck around a patient’s tissue during a procedure.

The U.S. Food and Drug Administration (FDA) announced the Olympus Single Use Ligating PolyLoop device instruction update on December 3, warning that continued use of the device without following the updated instructions could result in severe patient injury.

A Single Use Ligating PolyLoop device is a small medical tool doctors use to tighten a loop around tissue to prevent or control bleeding after removing a polyp, often with the help of an endoscope. The device works by tightening and releasing the loop, and it is discarded after a single use.

However, if the loop fails to release, it can cause severe tissue or mucosal injury, bleeding that may require a transfusion, perforation, additional surgery, long procedural delays and hospitalization.

Olympus has received at least 113 reports of serious injuries related to the issue, leading the FDA to classify the correction as the most serious type.

The affected Single Use Ligating PolyLoop devices have model numbers HX-400U-30, UDI 04953170368615, and were manufactured between September 22, 2022, and September 7, 2025.

After receiving reports of release failures, Olympus determined that the problem occurs most often when the device’s yellow tube shifts away from the handle during use, or when the handle’s slider is forced forward against resistance. If the loop becomes stuck, doctors may need to act quickly to remove it, and the method used can influence how serious the resulting risks are.

On November 3, Olympus sent a letter to all affected customers recommending the following:

• Always keep an Olympus loop cutter available.
• Be careful not to move the yellow tube joint away from the handle, as this can tighten the loop too early and prevent it from releasing.
• If a provider feels resistance, stop and do not continue pushing the slider.
• Keep the tube sheath straight to reduce friction and avoid added resistance.

Techniques not included in the instructions should be avoided unless emergency equipment listed in the device’s indications is unsuccessful or not available.

If standard emergency treatments such as using pliers, wire cutters or a loop cutter are successfully performed, the risks are generally limited to bleeding and minor delays, which can usually be managed.

However, if these standard methods fail or are not attempted and alternative techniques are used instead, the risks increase significantly and may require the patient to be moved to a higher level of care.

Customers in the U.S. with questions about this recall can contact Olympus at 1-800-848-9024 and select option 1.

Olympus Endoscope Device Recalls

This is not the first time Olympus has experienced issues with medical products related to its endoscope devices. An endoscope needle recall was issued in September, following a patient’s death.

The company also issued an Olympus endoscope guide sheath kit recall earlier this year, after detached tips inside patients caused dozens of serious injuries.

In addition, Olympus issued a recall of certain endoscopes due to bacterial contamination toward the end of last year, which resulted in at least 120 patient injuries and one death.

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