Dive Brief:
- Abbott is recalling a system monitor used with the Heartmate cardiac pump because screen display issues could pose a risk to patients. The Class 1 recall affects 4,842 monitors distributed in the U.S. and worldwide, according to a June 7 database entry by the Food and Drug Administration.
- In an urgent medical device correction letter to physicians in May, Abbott said no serious adverse health consequences were reported and no devices are being removed from the market.
- The latest recall follows three others from earlier this year involving the Heartmate left ventricular assist system, the only such mechanical circulatory support device on the U.S. market after Medtronic stopped selling its Heartware pump in 2021.
Dive Insight:
The Heartmate pump provides short- or long-term circulatory support for heart failure patients. The device takes over pumping for the left ventricle, the heart’s main pumping chamber. It can be used to help the heart recover, while waiting for a heart transplant or as a permanent implant.
In its letter to physicians, Abbott said all Heartmate system monitors have the potential for screen display issues, but restarting the monitor resolves the problem in most cases.
Still, Abbott warned its customers that the screen display issues could lead to hemodynamic compromise if the heart pump’s settings are accidentally changed, potentially causing patients to not get enough blood flow. The company said it had not received any complaints related to this risk.
Abbott received 299 system monitor complaints between January 2012 and April 2024. The issues included overlapping screens or buttons, unresponsive buttons, the screen freezing, distorted text and zeros or blanks in place of values.
Thirteen complaints reported that the “Stop pump” command was accidentally selected due to a display issue, causing the heart device to momentarily stop and automatically restart. Patients did not present symptoms due to the pump stopping, Abbott said.
The company received 22 complaints of extended surgical times because the unit was restarted or replaced with a backup. Meanwhile, the rest of the complaints described anxiety or user inconvenience.
The Heartmate Touch, a newer communication system for managing patients with Heartmate II and Heartmate 3 devices, is not affected, Abbott said.
“As part of our recent communication, Abbott counseled physicians and clinics on how to overcome this atypical screen behavior and the importance of utilizing the newer HeartMate Touch controller to avoid challenges with the former System Monitor,” a company spokesperson said in an email.
In the three previous recalls involving Heartmate devices this year, no products were removed from the market.
In March, Abbott recalled the Heartmate 3 system after a sealing issue during implant was tied to 70 injuries and two deaths. The company recalled Heartmate II and Heartmate 3 systems in February due to the potential for a buildup of biological material to obstruct the pumps. That recall was linked to reports of 273 injuries and 14 deaths.
In January, Abbott recalled a version of the Heartmate Touch communication system due to a risk that it could cause the pump to stop or start unintentionally. Eight related injuries were reported.
Abbott got Heartmate as part of its purchase of St. Jude Medical in 2017, two years after St. Jude acquired the technology when it bought Thoratec.
Heartmate became the only remaining left ventricular assist device on the U.S. market in 2021 when the FDA advised healthcare providers to stop implanting Medtronic’s Heartware device due to the frequency of adverse events and mortality associated with the system. Medtronic ended sales of the device.
