Recall of Covidien EEA™ Auto Suture™ Circular Stapler with DST Series™ Technology, 25mm

A Dear Healthcare Professional Letter has been issued by Medtronic International Ltd to inform healthcare professionals of the recall of Auto Suture™ Circular Stapler with DST Series™ Technology, 25mm, model numbers EEA25, EEAXL25, EEA2535, and EEAXL2535 due to potential for the staple guide not to be securely attached to the instrument. Disengaged staple guides could allow the device to transect tissue without forming staples. This could result in delayed treatment, extended hospital stays, unspecified tissue injury, unintended radiation exposure, unexpected medical intervention, foreign body in patient, failure to anastomose, and haemorrhage. Healthcare professionals are advised to return all unused affected devices to Medtronic. In patients who had used the device, no additional actions are required; healthcare professionals are advised to monitor them in accordance with their medical facility’s standard care protocols. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

27 May 2022

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.