Abbott has recalled the Pocket System Controller for the Thoratec HeartMate II left Ventricular Assist (LVAS) following 70 reports of adverse incidents that have resulted in at least 19 injuries and 26 deaths. Nearly 29,000 devices are covered by the recall.
According to the notice from the U.S. Food and Drug Administration (FDA), the problem with the device arises when patients attempt to change to the backup system controller while in the midst of therapy. If the changeover takes place too slowly or is otherwise done ineffectively, the patient is at risk of injury or death.
The manufacturer emphasizes that there is currently no recommendation that physicians remove the HeartRate II from patients who have already had the device implanted. Although listed by the FDA as a Class I recall, the focus is on the controller.
Abbott also hopes to use the recall to raise awareness among patients about the proper way to handle maintenance related to the HeartRate II. Although patients are typically supplied with replacement battery units, the recommendation is that they perform the component exchange only in emergency situations. All other switches should be performed by a clinician in a healthcare facility.
“Despite past efforts to improve training and education, we are aware of patients experiencing a very low level of adverse events as a result of unnecessary patient controller exchanges,” Abbott spokesman Justin Paquette told the Star Tribune in an emailed statement. “We are updating its alert guides, conducting a software upgrade, and adding controller alignment markings for the HeartMate II System Controller as part of a continued effort to ensure patients are successfully able to exchange their pocket controller in emergency situations.”
Impacted patients were mailed a letter after the recall was initiated in March.
Filed Under: Industry regulations