By Joe Carlson

Minneapolis Star Tribune

At least 26 patients with advanced heart failure have died after trying to replace the controller for their HeartMate II blood pumps while out of the hospital.

Abbott Laboratories has issued a device alert for 28,882 HeartMate II controllers that includes new software and alarm guides, following reports of 70 incidents in which the life-preserving device has malfunctioned after a patient changed out the controller at home. Those incidents include 26 deaths and 19 injuries.

“Patients may sometimes need to change to their backup back-up system controller during the course of ventricular assist therapy. The change should be done quickly and in the hospital, because it can present a significant challenge to patients that are elderly and/or untrained. For these patients, a slow or improper … changeover places them at risk of serious injury or death,” according to a recall notice from the Food and Drug Administration.

Abbott — which acquired St. Jude Medical and its HeartMate II Left Ventricular Assist Device (LVAD) in January — sent the product alert to doctors across the country on March 30. After the market closed Tuesday, the Food and Drug Administration issued a recall notice classifying the Abbott communication as a Class 1 recall, the most serious category.

A LVAD is an implantable device with a six-figure price tag that essentially pumps a person’s blood when the heart is too weak to do it on its own. The device was originally intended to keep a person alive just long enough for them to get a heart transplant, but in 2010 the FDA approved the HeartMate II as a “destination therapy” for people who can’t qualify for heart transplantation due to age or other factors.

The implanted device includes a Pocket System Controller that is outside the body, which needs to be replaced periodically. Abbott recommends that patients have these controller exchanges done in the hospital or clinic, not at home.

An e-mail from spokesman Justin Paquette described what’s happening:

“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.”

“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,” he said.

“This has been classified by the FDA as a Class I recall, however this is not about recalling products; 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 guide patients to talk to their physician when the time is approaching to have their controller exchanged,” he said.

The recall notice can be found at https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm560200.htm
—Distributed by Tribune Content Agency.