This recall involves updating instructions for using certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.    

Affected Product

The FDA is aware that Olympus has issued a letter notifying affected customers that Single Use Ligating Devices have updated use instructions:

  • Device Name: Single Use Ligating Device PolyLoop
  • Model/Catalog Number: HX-400U-30
  • Manufactured Date Range: September 22, 2022 – September 7, 2025
  • UDI: 04953170368615

What to Do

Adhere to the warning and caution statements in the instructions for use. Be aware of the supplemental guidance provided for the safe use of the PolyLoop device.

On November 3, 2025, Olympus sent all affected customers a letter recommending the following actions:

  • Carefully read the contents of the letter, including the supplemental guidance and reinforced text from the instructions for use.
    • Always have Olympus loop cutter available when using the PolyLoop device.
    • When operating the yellow tube joint (yellow cylinder), be careful not to move it away from the handle, prematurely tightening the loop which may cause the inability to release the ligation loop.
    • If resistance is encountered, do not continue or force the advancement of the slider located on the device handle.
    • Maintain a straight position of the proximal end of the tube sheath to prevent increased frictional resistance which may lead to breakage of the operating pipe when the slider is pushed (Figure 2).
  • Ensure all personnel are completely knowledgeable on the content of the notification. You may continue to use the device and are reminded of the importance of adhering to the warnings that are present in the instructions for use.
  • Use of techniques not outlined in the instructions for use should be avoided unless emergency equipment listed within the indication for use is unsuccessful and/or unavailable.
  • Acknowledge receipt of the letter through Olympus’s recall web portal:
  • If you have further distributed this product, identify your customers and forward the notification to them.

Reason for Correction

Olympus received complaints indicating that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally anchored in place around patient anatomy.

Olympus’s preliminary investigation into complaints regarding the inability to release the ligation loop found that the failure was caused by the following:

  • Inadvertent or intentional movement of the yellow tube joint (cylinder) away from the device handle during use. Intentionally moving the yellow tube joint away from the handle to prematurely tighten the loop during use may cause the inability to release the ligation loop (see figure 1 below).
  • Forceful advancement of the slider located on the device handle when resistance is encountered may cause an inability to release the loop.
tube sheath with red arrows

An unreleased ligation loop stuck within the sheath presents procedural challenges as emergency intervention may be required to remove the device from the patient’s anatomy, and the method used for removal significantly influences the severity of these risks. Use of techniques not outlined in the instructions for use should be avoided unless emergency equipment listed within the indication for use is unsuccessful and/or unavailable.

If standard emergency treatment, such as the use of pliers/wire cutters, and a loop cutter is successfully performed as outlined in section 12 of the instructions for use, the associated risks are generally limited and may include bleeding and minor procedural delays, which can typically be managed with endoscopic hemostasis clips.

However, if standard removal methods are unsuccessful or not attempted, and alternative techniques are used outside of the instructions for use guidance, the risks are significantly increased, and potential escalation to higher levels of care are possible. The associated risks may include severe tissue/mucosal injury, bleeding with the potential need for transfusion, perforation, additional surgical intervention, extensive procedural delays, and hospitalization.

As of October 1, 2025, Olympus has reported 113 serious injuries, and no deaths associated with this issue.

Device Use

The Single Use Ligating Device PolyLoop is designed to be used with an Olympus endoscope to deliver a nylon loop snare intended to prevent or control bleeding following a polypectomy of pedunculated polyps.

Contact Information

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

Additional FDA Resources:  

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.  

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.