Snare, Non-electrical
Gastroenterology, Urology · 21 CFR 876.4730
Recent MDR events
572 adverse event reports on file
- EXACTOJul 16, 2026MalfunctionUs Endoscopy1528319-2026-00082
- CAPTIVATOR COLD SINGLE-USE SNAREJul 15, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02822
- CAPTIVATOR COLD SINGLE-USE SNAREJul 6, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02689
- CAPTIVATOR COLD SINGLE-USE SNAREJul 6, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02691
- CAPTIVATOR¿ COLDJun 29, 2026MalfunctionBoston Scientific Corporation25650491
- CAPTIVATOR COLDJun 18, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02517
- CAPTIVATOR COLD SINGLE-USE SNAREJun 16, 2026InjuryBoston Scientific Corporation3005099803-2026-02488
- CAPTIVATOR? COLDJun 15, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02440
- Captivator COLD Single-use snareJun 15, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02461
- CAPTIVATOR? COLDJun 15, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02464
Event type breakdown
Recalls
47 recall events for this product code
- Endo-Therapeutics, Inc.TerminatedNov 18, 2022
eSuction Small Cavity, Model ET2005
Improper device regulatory classification
Z-0270-2023 · View FDA record ↗ - Boston Scientific CorporationTerminatedJan 11, 2014
TWISTER PLUS 22mm Rotatable
Sterility of device may be compromised due to lack of pouch seal integrity
Z-0719-2014 · View FDA record ↗ - Boston Scientific CorporationTerminatedJan 11, 2014
TWISTER PLUS 22mm Rotatable
Sterility of device may be compromised due to lack of pouch seal integrity
Z-0720-2014 · View FDA record ↗ - Boston Scientific CorporationTerminatedJan 11, 2014
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration)
Sterility of device may be compromised due to lack of pouch seal integrity
Z-0721-2014 · View FDA record ↗ - Boston Scientific CorporationTerminatedJan 11, 2014
TWISTER PLUS 26mm Rotatable Retrieval Device
Sterility of device may be compromised due to lack of pouch seal integrity
Z-0722-2014 · View FDA record ↗ - Boston Scientific CorporationTerminatedJan 11, 2014
TWISTER PLUS 26mm Rotatable Retrieval Device
Sterility of device may be compromised due to lack of pouch seal integrity
Z-0723-2014 · View FDA record ↗ - Boston Scientific CorporationTerminatedJan 11, 2014
TWISTER PLUS 26mm Rotatable Retrieval Device
Sterility of device may be compromised due to lack of pouch seal integrity
Z-0724-2014 · View FDA record ↗ - Aomori Olympus Co., Ltd.TerminatedUnknown
SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps,
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Z-0991-2021 · View FDA record ↗ - Aomori Olympus Co., Ltd.TerminatedUnknown
SD-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usage: Used with endoscopes for the removal and/or cauterization of diminutive polyps,
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Z-0992-2021 · View FDA record ↗ - Aomori Olympus Co., Ltd.TerminatedUnknown
INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophage
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Z-0993-2021 · View FDA record ↗
Registered firms
70 firms currently registered for this product code
Jiangsu Vedkang Medical Science And Technology Co.,ltd.
Changzhou Jiangsu, CN
Boston Scientific Corporation
El Coyol Alajuela, CR
Wuxi Goals Medical Technology Co., Ltd.
Yixing Jiangsu, CN
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Aomori Olympus Co., Ltd. Kuroishi Site
KUROISHI-SHI Aomori, JP
Isomedix Operations Inc.
S Plainfield, NJ, US
Conmed Corporation
WESTBOROUGH, MA, US
Hangzhou Goals Medical Technology Co., Ltd.
Hangzhou Zhejiang, CN
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Diversatek Healthcare Inc
Milwaukee, WI, US
Goals Sterilization Co., Ltd
Jiaxing City Zhejiang, CN
Diversatek Vietnam Company Limited
Thuan An City Binh Duong, VN
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Yangzhou Jiangsu, CN
Pti Engineered Plastics
Macomb, MI, US
Meditalia S.r.l..
Palermo, IT
Aspen Surgical Products, Inc.
Caledonia, MI, US
Alton Shanghai Medical Instruments Co Ltd
Shanghai, CN
Endo-therapeutics, Inc.
CLEARWATER, FL, US
United States Endoscopy Group, Inc.
Mentor, OH, US
Jiangsu Power-endo Medical Technology Co., Ltd.
Changzhou Jiangsu, CN
Jiangsu Grit Medical Technology Co., Ltd.
changzhou Jiangsu, CN
Finemedix
Daegu Gwangyeogsi, KR
Changzhou Emanmed Biotechnology Co., Ltd
Changzhou Jiangsu, CN
Jiana Sterilization Technology (hangzhou) Co., Ltd
Hangzhou Zhejiang, CN
Boston Scientific Limited
GALWAY, IE
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.