Urgent Medical Device Recall for HeartWare® Ventricular Assist System batteries
Healthcare professional
Medical devices
20 January 2016
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HeartWare Inc (HeartWare) would like to inform healthcare professionals of the voluntary recall of selected HeartWare® Ventricular Assist System Batteries that are likely to exhibit deterioration of battery capacity. Based on ongoing monitoring of power management complaints, it was shown that fewer complaints originated from patients with batteries having cells from the new cell supplier. Thus, HeartWare is recalling any remaining batteries from the previous cell supplier to help reduce premature or unrecognized battery depletion events. Healthcare professionals are advised to quarantine and return the affected products, including those in their patients’ possession, to HeartWare. Please refer to the letter for more 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.
