CVG-22-Q1-04 Heartware Ventricular Assist System (HVAD) System : Notify customers on stop distribution and sale

 

Affected Medical Device : Heartware Ventricular Assist System (HVAD)

 

MDA Reference Number : MDA/FCA/2021-P078

 

MDA Registration Number : GD74345985518

 

Decription : Medtronic is providing a voluntary FCA to notify customers on stop distribution and sale of the HVAD™ System, patients who currently have an HVAD™ implant may require support for many years. Medtronicwill continue to provide ongoing product support, including the Pioneer controller and peripherals, and Medtronicwill work diligently to mitigate potential risks associated with the HVAD™ System.Physicians should immediately stop new implants of the Medtronic HVAD™ System. Prophylactic explant of the HVAD™ System is not recommended at this time.

 

Local Establishment Contact Detail :

Wong Wai Yi
Medtronic Malaysia Sdn Bhd
B-23-01, The Ascent, Paradigm, No. 1, Jalan SS7/26A, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia
Office +603-78838000

Email : wong.waiyi@medtronic.com

 A copy of FSN.