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N1101 Nexus Ligator 1 Pack

INX MEDICAL, LLC · Model N1101-1 · UDI-DI 00861815000476

FHN Prescription

510(k) clearances

2,058

Adverse events (8 deaths)

Recalls

Facilities

Description

The inx Medical Nexus Hemorrhoid Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue. The inx MedicaL Hemorrhoid Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with preloaded non-latex rubber bands.

Recalls

Date	Firm	Reason
2011-07-19	Boston Scientific Corporation	Boston Scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away
2010-09-03	Cook Endoscopy	A section of the ligator barrel may separate from the barrels friction fit adapter that attaches to the patent end of the endoscope. This could result in a section of the ligator b
2009-06-17	Boston Scientific Corporation	The clip may not deploy or, if deployed, the clip may not release from the tissue.
2009-06-17	Boston Scientific Corporation	The clip may not deploy or, if deployed, the clip may not release from the tissue.
2004-01-15	Wilson-Cook Medical Inc	Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.