Attention: Endoscopy staff, risk management, and recall administration

Cook Medical has notified ACG, AGA, and ASGE of a medical device correction for the Hemospray Endoscopic Hemostat (HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU, all lots). The correction updates the Instructions for Use (IFU) to add device preparation steps supporting powder delivery and to outline mitigations for endoscope adhesion, with QR codes linking directly to a video on each topic. It is not a removal of devices from the field, and the notice extends to the user level.

What Is Changing

The updated IFU addresses two issues:

1. Endoscope adherence. Powder may adhere to the distal end of the endoscope, making it difficult to reposition or remove the scope. Risk increases with water-based lubricant, spraying in retroflexion, or withdrawal through narrowed anatomy.
2. Inability to spray powder. Powder may compact during shipping or storage, preventing the device from dispensing.

Actions for Endoscopy Units

• Keep the endoscope moving continuously during and after powder application.
• If adherence occurs, do not rotate, push, or pull the endoscope. Irrigate the shaft with saline — more effective than sterile water — to loosen the powder before any maneuver or removal.
• Limit disturbance of the treatment site to minimize rebleeding risk.
• Before use, agitate the powder: invert the handle and return it upright, tapping, flicking, or gently shaking the chamber only while inverted. Never do so upright — that further compacts the powder. Continue until the powder moves freely as the handle is flipped.
• Circulate this notice to all users and any organization receiving further-distributed product; update local procedure and competency materials.
• Complete and return the Cook Medical customer response form.
• Please contact your local sales representative with questions.

Letter and Related Resources

• Cook Medical Notification (August 14, 2026)
• Video: mitigation techniques for endoscope adherence
• Video: updated Instructions for Use for Hemospray

Questions
Cook Medical Customer Relations: 800.457.4500 or 812.339.2235.