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Health Sciences Authority
Dear Healthcare Professional Letters

Potential hairline crack at the power ports of the controller housing of selected Medtronic HeartWare™ HVAD™ Controller units

Audiences

Healthcare professional

Product type

Medical devices

4 September 2018

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

Emergo Singapore Consulting Pvt. Ltd. would like to inform healthcare professionals of the potential for hairline crack at the power ports of the controller housing of selected range of HeartWare™ HVAD™ Controller units. The root cause was determined to be a manufacturing issue. If a Controller develops a hairline crack and is unprotected from water or fluid exposure as described in the Information For Use (IFU), the unit may experience water or fluid ingress. This can lead to varying degrees of controller malfunction, including pump stop. No complaints have been received by Medtronic against the affected range of HVAD™ Controllers to date. Healthcare professionals are advised to reinforce to their patients the importance of protecting the device from water as per Patient Manual Instructions and to inform when their HVAD™ System Controller is exposed to water or fluid outside of conditions described in the IFU and Patient Manuals. 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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