Olympus Corporation of the Americas recalled 7,803 HX-400U-30 single‑use ligating devices distributed nationwide in the United States. The ligation loop may fail to release or detach. Hospitals and clinics should stop using the device immediately and follow the recall instructions from Olympus or their healthcare providers.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The HX-400U-30 is a single-use endoscopic ligating device that delivers a nylon loop snare during certain procedures. It is used in conjunction with an Olympus endoscope.
If the ligation loop cannot release or detach, it may stay fixed around patient tissue or anatomy, potentially causing constriction or injury during a procedure.
This recall is not described as part of a broader industry pattern.
Hospitals may need to pause procedures involving HX-400U-30 until replacement devices or guidance are issued. The recall affects 7,803 units distributed nationwide.
Recall letters, FDA recall page, and Olympus official notices
Replacement or remediation timelines typically 4-8 weeks depending on recall logistics
Keep recall letters, correspondences, receipts, photos of devices and packaging, and notes of any clinical decisions related to the recall
Model/Catalog Number: HX-400U-30 UDI: 04953170368615 All Lots which have not expired Quantity: 7803 units Distribution: US-wide distribution Sold at: Unknown When sold: Unknown Price: Unknown
No injuries or incidents have been reported.
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