FDA designates recall of display used with LV assist system as class I
Key takeaways:
- The FDA designated Abbott’s recall of its LV assist system monitor as class I, the most serious type.
- Issues with the monitor’s display may cause a user to inadvertently change pump settings or stop the pump.
Abbott issued a recall and correction for its left ventricular assist system monitor due to atypical behavior of the device screen that may cause unintentional pump stop.
The FDA has identified the recall of this device (HeartMate System Monitor, Abbott) as a class I recall, the most serious type of recall, as use of the device may cause injury or death. The FDA noted that this recall is a correction and not a product removal.
The monitor is used in the operating room or during clinic visits to monitor the system during implantation, display information about the system, program certain parameters and view and track alarm data, among other tasks, according to an alert from the FDA.
Atypical screen behavior includes freezing, distorted text, overlapping text, wrong or missing information and unresponsiveness that may cause a user to unintentionally change the pump’s setting or press the pump stop button, according to the alert.
The correction includes all system monitor lots and serial numbers.
There have been 14 reported injuries and no deaths related to the issue.