Field Safety Notice Cook Medical Instinct Plus Endoscopic Clipping Device (ICN 3272)

NHSSC: 114

Alert:

• Cook Medical has issued Field Safety Notice FSN and FSCA Ref: 2026FA0002 recalling Instinct Plus Endoscopic Clipping Devices manufactured 2023-02-09 through 2025-04-20, following reports of a malfunction that occurs when the user attempts to open the clip jaws by actuating the handle.
• The Instinct Plus Endoscopic Clipping Device is intended for endoscopic clip placement within the gastrointestinal tract.
• The malfunction that may occur is the clip housing detaching from the catheter attachment and the clip remaining attached to the drive wire.
• Cook Medical advise potential hazardous situations that could occur due to this malfunction are significant delay in procedure, foreign object detachment in the patient, clip not deploying as intended, additional hemostasis treatment, or a sharp object exposed at the patient end of the device.
• Potential harms to the patient that may occur with the above hazardous situations are bleeding that may or may not require intervention, surgery or interventional radiology, rebleed, perforation, laceration or other injury, mucosal tearing or irritation, hospitalization for observation, endoscopic retrieval of an object, aspiration, intubation, or death.
• Cook Medical describe the probability of this incident occurring as occasional. With the predicted risk to patients/ users based on current performance supporting a risk level of negligible to low with a worst-case potential risk of high.

Products Affected:

• One product is affected.
• The affected product is available via NHS Supply Chain’s eDirect Service:

• Please note this Field Safety Notice supersedes Cook Medical’s previous communication 2025FA0005 on our Product Alert ICN 3039 dated August 2025.
• See our Useful Links to view ICN 3039.
• Cook Medical advises they are now voluntarily removing certain lot numbers from the field because they were manufactured prior to implementation of updated manufacturing processes, which are intended to reduce occurrences of this device malfunction.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine all affected products.
• See our Downloads ▼ section to complete the Customer Reply Form and email to: FieldAction@CookMedical.com
• Where product is indicated as being available for return, Cook Medical’s Customer Services department will contact you to organize the return and issue you with the relevant Returns Authorization number.
• Please also contact your local NHS Supply Chain Customer Service Advisor with details of the products for collection by Cook Medical, together with the Returns Authorization Number, to enable us to manage your credit.
• Cook Medical confirm they have identified and already contacted all affected customers.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Acute team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.