Medtronic Recalls HVAD Batteries, Monitors, Adapters

Medtronic initiated recall of devices, according to FDA filings.

• FDA identifies this as a Class I recall, the most serious type of recall
• Recalls affect Medtronic HVAD battery, with 114,133 devices in commerce (66,613 in the U.S.), also:
  • HVAD packaged monitor, HVAD alarm adapter, Controller AC adapter, HVAD monitor data cable, HVAD controller
• There is the potential for the controller power cables, HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD controller ports when inserting the cables into the controller ports, due to wear from misalignment of the cables to ...