The US Food and Drug Administration (FDA) has tagged a recall of Abbott’s HeartMate Touch System as Class I, the most serious designation for a medical device.
The recall for Abbott’s communication systems is a correction as opposed to a product removal, as per an FDA notice.
The FDA tag follows a letter sent by Abbott in January 2024, highlighting complaints related to the device. There have been eight reported injuries, three of which occurred during surgery.
The recall involves more than 1,500 devices in the US distributed between May 2020 and January 2024.
The HeartMate Touch System is normally used to monitor patients who have an implantable HeartMate 3 left ventricular assist device (LVAD). The touch communication system works with the HeartMate system controller and together are used by healthcare professionals to gain an insight into patient cardiovascular status.
The reason for the recall is an unexpected pump start or stop during certain disconnections between the touch system and controller. Abbott said that the unintentional starting or stopping of the LVAD was linked to when a specific command was initiated on the touch app and then communication was lost to the controller.
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A Class I recall designation means that continued use of the product could cause serious harm or death. According to the FDA alert, using the system could cause light-headedness, sudden changes in blood flow, and loss of consciousness. Though death is also a potential consequence, Abbott has reported no fatalities.
In a letter to customers, Abbott asked customers to not disconnect the system controller or pump until certain steps have been taken and to follow instructions when performing the “STOP PUMP” sequence.
“We sincerely apologise for any difficulties or inconvenience that this may cause you and your patients. Please know that Abbott is committed to providing the highest quality products and support,” Abbott stated in the letter.
Abbott also had a recall of its Proclaim neurostimulation systems and Infinity IPGs tagged as class I by the agency in September 2023.
