FA1180 HeartWare™ Ventricular Assist Device (HVAD™)System Pump Driveline Strain Relief Repair

 

Affected Medical Device : Heartware Ventricular Assist System (HVAD)

 

MDA Reference Number : MDA/FCA/2021-P128-2

 

MDA Registration Number : GD74345985518

 

Decription : Medtronic is providing a voluntary FCA to notify customers on important safety information related to HVAD™ Systems that have undergone a driveline strain relief repair performed by a Medtronic field service representative. Medtronic internal testing has shown that it may be difficult to pull back the driveline cover over a strain relief repair when attempting to access the driveline connector.

 

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 : [email protected]

 

 A copy of FSN.