Ligator, Hemorrhoidal
FDA adverse event reports and recall history for ligator, hemorrhoidal (product code FHN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,058
- Deaths
- 8
- Injuries
- 207
- Malfunctions
- 1,838
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2011-08-22TerminatedOther
The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery system. Endoscopic Clipping Device, Hemorrhoidal Ligator. The device is used for clip placement within the GI tract for hemostatis ( mucosal defects, bleeding ulcer, arteries, polyps); endoscopic marking; and anchoring to affix jejunal feeding tubes to the wall of the small bowel, as a supplementary method for closure of GI tract luminal perforation <20 mm that can be treated conservatively.
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 from the clip, resulting in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn.
- 2010-10-19TerminatedOther
Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105 This device is used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
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 barrel detaching inside the patients gastrointestinal tract.
- 2009-09-02TerminatedProcess control
Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522600 (1 clip) and M00522602 (20 clips). The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations.
The clip may not deploy or, if deployed, the clip may not release from the tissue.
- 2009-09-02TerminatedProcess control
Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522610 (1 clip) and M00522612 (20 clips). The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations.
The clip may not deploy or, if deployed, the clip may not release from the tissue.
- 2004-07-20TerminatedOther
Four Shooter Saeed Multi-Band Ligator
Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.
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