Snare, Non-Electrical
FDA adverse event reports and recall history for snare, non-electrical (product code FGX), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 568
- Deaths
- 0
- Injuries
- 59
- Malfunctions
- 507
Reports per year
Source: FDA adverse event reports by year received, 2001–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2022-11-18TerminatedOther
eSuction Small Cavity, Model ET2005
Improper device regulatory classification
- 2014-01-11TerminatedPackaging process control
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.
Sterility of device may be compromised due to lack of pouch seal integrity
- 2014-01-11TerminatedPackaging process control
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.
Sterility of device may be compromised due to lack of pouch seal integrity
- 2014-01-11TerminatedPackaging process control
TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.
Sterility of device may be compromised due to lack of pouch seal integrity
- 2014-01-11TerminatedPackaging process control
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.
Sterility of device may be compromised due to lack of pouch seal integrity
- 2014-01-11TerminatedPackaging process control
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica. Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.
Sterility of device may be compromised due to lack of pouch seal integrity
- 2014-01-11TerminatedPackaging process control
TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica.
Sterility of device may be compromised due to lack of pouch seal integrity
- TerminatedUnder Investigation by firm
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, sessile polyps, pedunculated polyps and tissue from within the GI tract.
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.
- TerminatedUnder Investigation by firm
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, sessile polyps, pedunculated polyps and tissue from within the GI tract.
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.
- TerminatedUnder Investigation by firm
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 esophageal and gastric varices and for submucosal injection in the digestive tract.
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.
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