Ligator, Hemorrhoidal
Gastroenterology, Urology · 21 CFR 876.4400
Recent MDR events
2,058 adverse event reports on file
- SMARTBAND SAFEGRIP MULTI-BAND LIGATION KITJun 16, 2026MalfunctionUs Endoscopy1528319-2026-00069
- 10 SHOOTER SAEED MULTI-BAND LIGATORJun 15, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00281
- 10 SHOOTER SAEED MULTI-BAND LIGATORJun 12, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00278
- SPEEDBAND SUPERVIEW SUPER 7Mar 25, 2026MalfunctionBoston Scientific CorporationMW5185799
- 6 SHOOTER SAEED MULTI-BAND LIGATORMar 4, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00108
- 6 SHOOTER SAEED MULTI-BAND LIGATORFeb 9, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00068
- 10 SHOOTER SAEED MULTI-BAND LIGATORFeb 6, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00066
- 6 SHOOTER SAEED MULTI-BAND LIGATORFeb 6, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00067
- 10 SHOOTER SAEED MULTI-BAND LIGATORJan 5, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00004
- 10 SHOOTER SAEED MULTI-BAND LIGATOROct 16, 2025MalfunctionWilson-cook Medical Inc1037905-2025-00718
Event type breakdown
Recalls
5 recall events for this product code
- Boston Scientific CorporationTerminatedAug 22, 2011
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 s
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the clip, resulting in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn.
Z-3056-2011 · View FDA record ↗ - Cook EndoscopyTerminatedOct 19, 2010
Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105
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.
Z-0091-2011 · View FDA record ↗ - Boston Scientific CorporationTerminatedSep 2, 2009
Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA;
The clip may not deploy or, if deployed, the clip may not release from the tissue.
Z-1895-2009 · View FDA record ↗ - Boston Scientific CorporationTerminatedSep 2, 2009
Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA;
The clip may not deploy or, if deployed, the clip may not release from the tissue.
Z-1896-2009 · View FDA record ↗ - Wilson-Cook Medical IncTerminatedJul 20, 2004
Four Shooter Saeed Multi-Band Ligator
Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.
Z-0536-04 · View FDA record ↗
Registered firms
95 firms currently registered for this product code
Well Care (wuhan) Medical Technology Co., Ltd.
Wuhan Hubei, CN
Weco Manufacturing Group-henrietta
Rochester, NY, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Technimen Skillers
SIALKOT Punjab, PK
Hayden Medical Inc
Valencia, CA, US
Sapi Med S.p.a
ALESSANDRIA, IT
Aesculap, Inc.
CENTER VALLEY, PA, US
Scanlan International, Inc.
Saint Paul, MN, US
Teleflex Medical Llc
Morrisville, NC, US
Changzhou Health Microport Medical Device Co.,ltd.
Changzhou Jiangsu, CN
Lhc Power Bander Llc
Milford, OH, US
Conmed Corporation
Utica, NY, US
Conmed Corporation
WESTBOROUGH, MA, US
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Zhuji Pengtian Medical Instrument Co.,ltd.
Zhuji Zhejiang, CN
Aspen Surgical Products, Inc.
Caledonia, MI, US
Jarit Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Madina Surgical Works
Sialkot Punjab, PK
Hazel Enterprises
Sialkot Punjab, PK
Allwin Medical Devices Pvt. Ltd.
Surat Gujarat, IN
Beijing Zksk Technology Co., Ltd.
beijing, CN
United States Endoscopy Group, Inc.
Mentor, OH, US
Fetzer Medical Gmbh & Co.kg
Tuttlingen Baden-Wurttemberg, DE
Micro-tech (nanjing) Co., Ltd.
NAN JING Jiangsu, CN
Novo Surgical, Inc.
Westmont, IL, US
510(k) clearances
22 clearances for this product code
- Beijing Zksk Technology Co., Ltd.Jun 6, 2022
K213223 · Multi-Band Ligator
- Leo Medical Co., Ltd.Jun 14, 2018
K172985 · Ligation Device
- Agency For Medical Innovations GmbHJun 12, 2015
K150718 · Wi-3 HAL-RAR System
- Inx MedicalJul 11, 2013
K131282 · NEXUS HEMORRHOID LIGATOR
- Thd SpaJul 15, 2010
K093497 · THD BANDY
- Haemoband Surgical, Ltd.Jul 28, 2009
K091519 · HAEMOBAND MULTI-LIGATOR
- Sapimed S.P.A.Sep 26, 2007
K070881 · LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
- Boston Scientific CorpApr 12, 2002
K020824 · SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238