Voluntary recall of selected Covidien Endo GIA articulating reloads with Tri-Staple technology following reports of potential failure

A Dear Healthcare Professional letter has been issued by Covidien Pte Ltd to inform healthcare professionals of the voluntary recall of selected Covidien Endo GIA articulating reloads with Tri-Staple technology due to the potential for the device to be missing one of two pin components that maintain alignment of the device jaws. Use of a product without a pin may result in incomplete staple formation, leading to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in infection and/or sepsis. Effects on the staple line should be immediately evident to the surgeon in the form of incomplete staple formation, malformed staples, or bleeding. Healthcare professionals are advised to monitor existing patients implanted with the device in accordance to current institution protocols and standard of care, and exercise clinical judgement while considering necessary follow-up actions. Please refer to the letter for details.

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

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.