Patients and healthcare providers are advised of a Class I recall of Abbott’s HeartMate Touch System (version 1.0.32) due to the potential for unexpected stops and starts in its pump, which could lead to serious injuries or death, according to the FDA.
Officials say 1,560 devices that were distributed across the U.S. between May 7, 2020 and December 18, 2023 are covered under the recall, which was announced by the company on January 3, 2024.
Used to monitor patients with an implantable HeartMate 3 Left Ventricular Assist Device, The HeartMate Touch Communication System is typically used with a HeartMate System Controller. It comes with “a tablet, wireless adapter, flash drive, power adapter, and USB,” and is used exclusively by clinicians in hospitals or clinics to present a patient’s cardiovascular status in a detailed and large-scale display to facilitate situations in which close monitoring of a patient is needed, such as during implant procedures.
Officials say they took action after identifying a risk to patients whose implanted devices undergo either an unanticipated pump stop or start. Customers should also be aware of the potential issues arising out of a HeartMate Touch System losing connection with a patient’s HeartMate Controller during a “pump stop” command is in operation.
A user may face the following issues:
- The pump will either stop or start, depending on the pump’s status at connection, when the HeartMate Touch is reconnected to the same or a different controller.
- The pump will restart if stopped at reconnection.
- A pump stop will occur in the event that the pump is running at reconnection.
Users should be aware that no alarms or other warnings will alert users that the “pump stop” command remains in “the command queue.”
As of this writing the company has received 8 reports of related injuries, and no deaths related to the issue.
Those who use an affected system may suffer major health consequences that include: “lightheadedness, sudden change in blood flow, loss of consciousness, and death.”
Those who elect to use an affected system may be subjected to a number of major adverse health consequences, depending. In the event that the pump is working during reconnection, the pump stop should be restarted. Officials indicate that in the event that a patient’s HeartMate Controller indicates a “pump stop” command is active,
An Urgent Medical Device Correction Letter issued to all of Abbott’s impacted customers (those with the implantable HeartMate 3 Left Ventricular Assist Device and those who use it to monitor patients with the devices) in January 2024 made the following requests of customers:
- When conducting the “STOP PUMP” sequence, refer to Pages 4-58 to 4-59 of the Instructions for Use Chapter 4 HeartMate Touch Communication System.
- Wait for the “STOP PUMP” sequence screen showing the red progress bar to disappear, and for the “STOP PUMP” screen to automatically change BEFORE disconnecting the HeartMate System Controller white cables or the Power Module’s Wireless Adapter.
- Wait until the timer reaches zero, for the pump to stop, and for the “Priming is complete” message to display BEFORE connecting the pump during pump priming.
Abbott Technical Support may be reached for further questions and concerns about the recall 1-800-456-1477.
Those who observe adverse reactions or quality issues with the devices are asked to report them to the FDA’s MedWatch program.
Have you or a loved one suffered an injury and/or other adverse health outcome that can be traced to a compromised medical device? Our attorneys at TruLaw work tirelessly to help families like yours demand fair compensation and hold negligent parties accountable following a traumatic experience. Connect with us online or take our free Instant Case Evaluation ℠ to learn more.