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Health Sciences Authority
Dear Healthcare Professional Letters

Recall of subset of unused Endurant™ and Endurant™ II/IIs Stent Graft Systems due to potential delivery system component failure

Audiences

Healthcare professional

Industry member

Product type

Medical devices

4 January 2022

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Medtronic to inform healthcare professionals of the recall of a subset of unused Endurant™ and Endurant™ II/IIs Stent Graft Systems that may be susceptible to a delivery system component failure. There is potential for devices built with specific batches of taper tip assemblies to have the taper tip detached from the delivery system during the implant procedure. This may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential for the taper tip to be intentionally left behind in the patient at the physician’s discretion if it is not easily removable. While serious injuries and/or deaths could occur due to detachment of the taper tip from the delivery system during the implant procedure, there are no increased risks or additional actions required for patients with successful deployment of the Endurant™ or Endurant™ II/IIs Stent Graft System since the taper tip detachment can only occur during stent graft deployment. Healthcare professionals are advised to quarantine and return all unused affected devices 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.

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