Voluntary recall of specific lots of Endurant™/Endurant II™ 23mm and 25mm Bifurcated Stent Graft Systems due to permeability variation

Medtronic International Ltd is notifying healthcare professionals of a recall of specific lots of Endurant™/Endurant II™ 23mm or 25mm Bifurcated Stent Graft System. This specific subset of stent grafts have greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure. This may cause the physician to misclassify a Type IV endoleak (which typically self-resolves over time) as an acute Type III Fabric endoleak, leading to unnecessary secondary interventions. Healthcare professionals are advised to quarantine and return all unused affected devices to Medtronic. Patients already implanted with a device affected by this recall should continue to be monitored in accordance with physician’s standard practice. 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.