Devices

FDA Class 1 Recall on Medtronic Field Action

David McFarland

— 1 min read
Share

FDA has classified as a Class 1 recall a Medtronic voluntary field action related to its HVAD System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435). FDA approved an updated controller on 4/7 and Medtronic began notifying U.S. clinicians about the updated HVAD Controllers and DC Adapters on 4/14, according to a company release. The updated controller includes enhancements designed to address potential safety issues, including:  

  • strengthened power and serial port alignment guides intended to reduce the incidence of wear that could lead to damaged connector pins;
  •  functionality designed to monitor internal battery performance and sound an alert when the internal battery is nearing depletion; and
  • redesigned connectors and housing intended to prevent the risk of connectors loosening or becoming more vulnerable to damage from exposure to water and other fluids.

Read more