Recall of Software and Urgent Field Safety Notice according to HeartAssist 5 LVAS, MicroMed Cardiovascular Inc.
2012.02.22
Product group Active implantable medical devices - artificial hearts
Reference 00980/11
Recall of Software and Urgent Field Safety Notice made by MicroMed Cardiovascular Inc., Houston, Texas, USA, according to HeartAssist 5 LVAS due to possible risk of insufficient electric charging of the battery packs SmartPack provided by HeartAttendant, the patient home unit for monitoring, power supply, telemonitoring and battery-charging.