FDA designates recall of LVAD communication system as class I
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Key takeaways:
- The FDA designated Abbott’s recall of its LVAD communication system as class I, the most serious type.
- Status of the “pump stop” command at the time of disconnection may affect its function when reconnected.
Abbott announced it is recalling its left ventricular assist device communication system due to risk for unexpected pump stop or start.
The FDA has identified the recall of this device (HeartMate Touch System version 1.0.32) 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 communication system is designed for use with the company’s implantable LVAD (HeartMate 3) to monitor patients’ CV status during implant procedures or whenever close monitoring is required, according an alert from the FDA.
The issue may occur if the system is disconnected from a patient’s controller while a “pump stop” command is running and subsequently reconnected to the same or a new controller, according to the release.
If the pump was stopped at reconnection, the pump will restart, but if the pump is running at reconnection, a pump stop will occur and there are no alarms or indications that warn the user that the “pump stop” command is still in the queue, according to the release.
The issue affects 1,560 devices distributed between May 7, 2020, and Dec. 18, 2023. There have been eight reported injuries and no deaths related to the issue.
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