—#216453

Product

Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.

FDA product code: MND — Ligator, Esophageal
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;

Why it was recalled

Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

Root cause (FDA determination)

Process control

Action the firm took

On October 30, 2025 and again on November 3, 2025, URGENT: MEDICAL DEVICE CORRECTIVE ACTION letters were sent to customers. Actions to be taken: Users are reminded of the importance of adhering to the Warnings and Cautions statements that are present in the instructions for use (IFU, ref: GK4574 Rev 16). A diagram was provided to illustrate the need to 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 piipe when the slider is pushed. Particular attention should be paid to the following key guidance within Sections 10 and 12 of the IFU. Carefully read the content of this letter, including the supplemental guidance and reinforced text from the IFU as noted above. a) Always have Olympus loop cutter available when using the PolyLoop device b) 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. c) If resistance is encountered, do not continue or force the advancement of the slider located on the device handle. 2. Ensure all personnel are completely knowledgeable on the content of this 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. 3. Olympus requests that you acknowledge receipt of this letter through our recall web portal. 4. If you have further distributed this product, identify your customers, and forward this notification to them.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US-wide distribution

Timeline

Recall initiated: 2025-10-30
Posted by FDA: 2025-11-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216453. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.