HeartMate II Left Ventricular Assist System Under Recall Due to Controller Exchange Problems

There have been 70 reports of incidents related to the exchange issue, including 19 injuries and 26 deaths.

An “Urgent Medical Device Correction” issued by Abbott-Thoratec for its HeartMate II LVAS Pocket System Controller has been classified by the US Food and Drug Administration (FDA) as a class I recall, the most serious type.

The action is due to risks of patient injury or death while exchanging the controller for a backup, which should be done quickly and in the hospital, according to the FDA announcement. Patients are given instructions and training on how to switch controllers in case of a device alarm or malfunction, but the process can be tricky.

Abbott-Thoratec said it has received reports of 70 incidents related to the issue, including 19 injuries and 26 deaths. All of the deaths occurred in patients who attempted to switch controllers outside of the hospital.

The company is addressing the issue with software and hardware updates aimed at easing controller exchanges.

A spokesperson for Abbott said in an emailed statement: “No products are being retrieved in this case; rather, the focus is on communication to physicians so they can ensure their patients have their controller exchange completed in a clinical setting. We have also updated our software and controller alerts to help patients connect with their physician's office when they need to have their controller exchanged.”

The recall, initiated at the end of March and involving 28,882 devices in the United States, affects devices with the following model/item numbers: 105109, 106015, 106762, and 107801. Affected products were manufactured between July 2012 and December 2016.


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