Hemostatic Device For Endoscopic Gastrointestinal Use
FDA adverse event reports and recall history for hemostatic device for endoscopic gastrointestinal use (product code QAU), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,066
- Deaths
- 9
- Injuries
- 157
- Malfunctions
- 900
Reports per year
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-12-02Open, ClassifiedNonconforming Material/Component
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.
- 2024-10-16Open, ClassifiedNonconforming Material/Component
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
Specific lots of product have been manufactured with nonconforming raw materials.
- 2023-06-21Open, ClassifiedUnder Investigation by firm
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.
- 2023-06-21Open, ClassifiedUnder Investigation by firm
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.
- TerminatedDevice Design
HEMO-7 Hemospray Endoscopic Hemostat
Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
- TerminatedDevice Design
HEMO-10 Hemospray Endoscopic Hemostat
Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.
- TerminatedUnder Investigation by firm
Hemospray Endoscopic Hemostat
Potential for Hemospray device to be unable to spray powder due to misassembly of devices.
Monitor hemostatic device for endoscopic gastrointestinal use automatically
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