Abbott Laboratories recalled nearly 29,000 controllers used with an implanted blood pump after more than two dozen heart patients died trying to replace the controller outside of a hospital setting.
Here are four things to know.
- The Pocket System Controller acts as an external power source for the HeartMate II LVAS pump, which circulates blood through the body when a patient's heart is too weak to carry out normal functions, according to a notice from the Food and Drug Administration.
- Abbott received 70 reports of issues involved with replacing the controller for a backup device, including 19 injuries and 26 deaths. Every death occurred when patients attempted to swap out the controller outside of a hospital, according to the FDA.
- The agency said swapping in a new controller "should be done quickly and in the hospital, because it can present a significant challenge to patients that are elderly and/or untrained," according to its safety notice.
- Abbott on March 30 issued a nationwide Class 1 recall — the most serious type — for 28,882 controllers distributed between July 2012 and March 2017. The company also sent letters to affected customers, notifying them of the safety issues. Abbott will provide all affected patients with new software and hardware updates to facilitate successful controller replacements during emergencies.
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