Abbott Medical has announced a Class I recall of its HeartMate LVAS System Monitor under all lots/serial numbers because a correction needs to be made to the Left Ventricular Assist System (LVAS) monitor, according to the FDA.
Officials say affected units have screen issues that may cause the device’s pump to stop unexpectedly. The recall was identified as Class I because use of an uncorrected device may lead to major injury or death.
As a component of a HeartMate Left Ventricular Assist System (LVAS), the HeartMate System Monitor is indicated for use in operating rooms or during clinic visits. The device enables and/or facilitates clinicians to do the following:
- Closely monitor system operation for the duration of an LVAD implant
- Displays current operating mode, pump flow and speed, the overall status of the operation, and other information regarding the system performance
- Set pump speed and other system parameters
- Evaluate and monitor alarm conditions
- Assess and save data demonstrating performance
- Capture and download data at selected intervals for analysis
In situations when the heart is unable to effectively pump blood on its own, a Left Ventricular Assist System (LVAS) facilitates the function. Patients can rely on the device during the wait for a heart transplant, can use it to support heart recovery. For those who are not able to receive a transplant, it can even be used as a “permanent solution.”
U.S. customers may direct any questions or concerns to their local firm representative or can contact Abbott Medical Technical Support at 1-800-456-1477.
Affected products can be recognized under either of the two UDIs (Unique Device Identifiers), and then under the following twelve model numbers:
UDI-DI:
Model Numbers:
- 1286
- L1286
- 1286A
- L1286A
- 1286A-US
- L1286A-US
- 1286C
- L1286C
- L1386
- 1286A-CAN
- 1286INT
- L1286INT
Abbott Medical said the recall was initiated after a number of screen issues were identified in the functioning of the HeartMate System Monitor (of the HeartMate LVAS): frozen screens, buttons and screens overlapping, unresponsive buttons, distortions in text or graphics, and missing or incorrect information shown on the display. Any one of these issues can lead a clinician to unintentionally altering the pump settings or stopping the pump altogether.
Because of these potential issues, customers are advised that using an uncorrected device may cause a number of adverse conditions or health outcomes. Notably, a pump stop could lead to a decrease in blood pressure and insufficient blood flow, or hemodynamic compromise, which can result in “brain damage, heart or organ failure, and death.”
To date of the June 28, 2024 FDA announcement, Abbott Medical has received 14 reports or related injuries, and no reports of death.
The letter provided guidelines for clinicians in a range of situations involving potential display screen issues:
- In the event that the unit has been running for a prolonged time, or if screen issues are noted, the System Monitor should be restarted before connecting to the patient controller.
- To initiate a full restart, which should take about 10 seconds, use the On/Off Switch (on the back of the System Monitor) to turn off and then turn on device.
- Users should note that if the unit is restarted while connected to the patient’s controller, the LVAD settings will not change.
- In the event that screen display problems persist even after the restart, check to ensure that all cables and connections are secure and not damaged.
- If the screen issues are still not resolved, use a different System Monitor.
- In the event that the “Stop Pump” button is accidentally pressed because of the display problems, note that the pump will briefly sop and then restart. However, if the “Stop Pump” button is held down for over 10 seconds, the pump will stop, and the controller’s “Pump Off Alarm” will sound.
- To attempt a pump restart and resolve the “Pump Off Alarm,” users are directed, per the Instructions for Use, to press any button on the controller.
An Urgent Medical Device Correction Letter sent to all impacted customers on May 8, 2024, reinforces that display issues can typically be resolved by restarting the System Monitor. The letter also makes the following requests:
- Ensure that the notice is distributed to all relevant personnel at any institutions where the potentially affected devices are known to be in use.
- Ensure that all relevant parties/institutions complete and submit the acknowledgement form via email to MCSHMNotices@Abbott.com.
As the FDA continues to oversee this recall, healthcare professionals and consumers are encouraged to report any related adverse experiences to the agency’s MedWatch Adverse Event Reporting Program.
If you or a loved one has suffered an adverse health outcome that can be traced to a clinician’s improper use of a medical device, your case warrants attention and your family deserves maximum compensation. Our attorneys at TruLaw have the experience and resources to help you fight for for the best outcome and hold the responsible party accountable. To learn about how we can help you begin building a case, we invite you to contact us or take our free Instant Case Evaluation ℠.