Voluntary recall of Covidien Endo GIA™ Auto Suture™ universal articulating loading units with potential for staple malformation

A Dear Healthcare Professional Letter has been issued by Medtronic International Ltd to inform healthcare professionals of a voluntary recall of specific lots of Covidien Endo GIA^™ Auto Suture^™ universal articulating loading units due to a potential for manufacturing assembly error that can contribute to staple malformation. The affected devices were distributed between June 2017 and July 2020. Use of a product with this assembly error may result in incomplete staple formation, leading to issues such as bleeding, anastomotic leak, pneumothorax or other delayed secondary complications, including infection and an increased risk of mortality. Manufacturing process improvements have been implemented to remediate this issue. As the effects on the staple line should be immediately evident to the surgeon in the form of incomplete staple formation, malformed staples, or bleeding, no further action is required if the patient has not experienced any staple-line related complications upon completion of operation with the affected products. Healthcare professionals are advised to immediately discontinue use of the unused affected items and return them to Medtronic. 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.