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Health Sciences Authority
Dear Healthcare Professional Letters

Potential for damage during pre-implant Outflow Graft and Strain Relief assembly procedure for Medtronic HeartWare™ HVAD™ System

Audiences

Healthcare professional

Industry member

Product type

Medical devices

9 April 2020

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 International Ltd to inform healthcare professionals that the outflow graft of Medtronic HeartWare™ HVAD™ System may be subjected to tears and the strain relief screw may break during the pre-implant pump assembly and attachment to the HVAD™ pump. The outflow graft tears may result in bleeding and have led to critical patient harm at a rate of 0.13%. No patient harm has been reported due to broken strain relief screws. Medtronic has provided additional steps for assembly and attachment to reduce the risk of damage and tearing during the assembly procedure in the letter. Healthcare professionals are advised to review these steps for future HVAD™ System implants and to inspect the grafts closely after assembly and before implantation for any possible tears. Medtronic is currently not retrieving the product from the field and no action is needed for patients currently implanted with an HVAD™ Pump. 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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