FDA-Device2025-12-03Class I
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.
Olympus Corporation of the Americas
Hazard
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.
Sold states
US-wide distribution
Affected count
7803 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0570-2026Don't want to check this manually?
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