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Health Sciences Authority
Dear Healthcare Professional Letters

Voluntary recall of HeartWare® Ventricular Assist Device (HVAD) sterile implant kits

Audiences

Healthcare professional

Product type

Medical devices

13 September 2016

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

HeartWare Inc (HeartWare) would like to notify healthcare professionals of the voluntary recall of specified HeartWare® Ventricular Assist Device (HVAD) sterile implant kit, including the HVAD pump, as they may be more susceptible to electrical faults if the driveline becomes contaminated. Contamination of the driveline-to-controller connector can occur during the implant procedure or post operatively from fluid ingress into the driveline. HeartWare has implemented manufacturing process improvements designed to prevent driveline connector contamination in new implant kits. Affected devices that have already been implanted into a patient are not subject for removal. Patients that experience electrical faults due to driveline connector contamination should be addressed per HeartWare’s HVAD Pump driveline connector cleaning procedure conducted by qualified HeartWare personnel. Please refer to 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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