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26 patients die after replacing Abbott blood pump controllers at home

May 24, 2017

Abbott Laboratories (ABT) is recalling for more than 28,000 of its HeartMate II blood pumps after 26 patients died after attempting to exchange controllers while away from the hospital.

According to the recall alert posted by the U.S. Food and Drug Administration (FDA), there were reports of 70 incidents in which the controller had malfunctioned after an exchange. Of those, 26 patients died and 19 were injured, according to the report. The FDA said the backup-system controller sometimes needs to be changed during the course of ventricular assist therapy. That change should be made in the hospital because the process can present a “significant challenge to patients that are elderly and/or are untrained.” An improper exchange places the patients at risk of injury or death, the FDA said.

Shares of Abbott are down this morning following the recall, trading at $43.45 as of 10:06 a.m.

In a statement to BioSpace Abbott said that although it is classified as a recall, no devices are actually being requested for return. The focus is on physicians so they can ensure their patients have their controller exchanged completed in a clinical setting, Laurel Hood, an Abbott spokesperson said. Additionally, Abbott said the company has updated the software for the device as well as controller alerts to “help patients connect with their physician’s office when they need to have their controller exchanged.”

Abbott acquired the HeartMate II device earlier this year in its $25 billion deal for Minnesota-based St. Jude Medical (STJ), the Minneapolis Star Tribune reported. The HeartMate II is a Left Ventricular Assist Device that is designed to pump a patient’s blood when the heart muscle is too weak to do it on its own.

Abbott first notified patients using the HeartMate II on March 29. The company sent an Urgent Device Correction letter to patients recommending upgraded hardware and software for the device, including a new lead.

The controller in question is a power supply that connects to the implanted HeartMate II device through a lead under the skin. Controllers for the HeartMate II are powered by batteries or are connected to a main power supply, the FDA said.

The HeartMate II was approved by the FDA as a stop-gap measure intended to keep patients alive long enough for a heart transplant. However, in 2010 the FDA approved the device as a “destination therapy” for patients who are unable to get a heart transplant due to age or other medical reasons, the Star Tribune said.

Abbott Spokesperson Justin Paquette told the Star Tribune in the email that the FDA’s recall was a Class I recall, the highest alert issued by the regulatory agency.

“…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,” Paquette said.

This isn’t the first time Abbott has had some issues with heart pumps. In February, the company halted use of the HeartMate PHP catheter following a patient death and multiple malfunctions, the Star Tribune reported. The HeartMate PHP catheterwas inserted into the heart to keep blood flowing at a predictable rate.

Following its acquisition of St. Jude, about one-third of Abbott’s business is comprised of cardiovascular and chronic pain management. At the time of the deal, Abbott said St. Jude Medical’s strong positions in heart failure devices complement Abbott’s positions in coronary intervention and transcatheter mitral repair.

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