ClearanceBrief
Recall Z-1903-2018 ยท DSQ Ventricular (Assist) Bypass

Heartware

Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS HVAD System: The HVAD System is intended for use in patients at risk of death

DateMay 21, 2018 (initiated May 2, 2018)
StatusOpen, Classified
ReasonPossible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.
Root causeDevice Design
ActionThe firm notified physicians and healthcare professionals about the device correction by letter on 05/02/2018. The letter explained problem and provided recommendations for effective power source management of the system. Medtronic began notifying VAD Clinicians in the US on May 31, 2018, mainly via 2-day courier, and OUS via locally approved methods, of a newly available field service. A field service for application of a lubricant to the HVAD System power source connectors to mitigate the potential for transient interruptions of the electrical connection between an HVAD System power sou
Quantity175878 devices
DistributionWorldwide Distribution including US Nationwide, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea, , Kuwait, Latvia, Le
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.