A recall of nearly 600 controllers used with LivaNova’s LifeSparc cardiac life support system has received its second Class I label from the FDA—this time, for a software update that aims to fix the issue that originally sparked the recall.
The LifeSparc system is used to keep blood pumping normally while patients are undergoing open surgeries of the heart or great vessels. It does so by routing the blood outside the body and then either through an oxygenator or merely around a disruption in the blood vessels. The single-use pump comes with a controller that’s used not only to manage the pump but also to provide the electricity and power needed to power the device.
Last year, LivaNova discovered a software issue that could cause the controller to malfunction. Specifically, the controller may mistakenly determine that the device’s software is frozen or unresponsive and therefore send the pump into “critical failure” mode, clearing the screen of what the system believes is incorrect data.
That mode and its accompanying alarms can only be resolved by replacing and then disconnecting the frozen controller, using very specific instructions; if those instructions aren’t followed correctly, the pump could stop for an extended period of time, causing an interruption in its life support functions.
At the time, in July 2022, the recall spanned 484 devices distributed in the U.S. since December 2019. The FDA gave the recall its Class I label—the agency’s most serious—after the company reported 66 complaints linked to the issue and the FDA received two reports of injuries. No patient deaths have been reported in tandem with the recall.
As LivaNova noted in a statement sent to Fierce Medtech on Monday, however, the recall didn’t require that any of the devices be removed from the market. Instead, the company alerted all users to the issue in July and updated the device’s instruction manual to make the “critical failure” resolution process clearer—and 100% of those users acknowledged the recall notice and updated instructions, per LivaNova. The company also said at the time that it was working on a software update that would address the root issue in the LifeSparc controllers.
That update arrived in early December, with LivaNova asking users simply to make their pumps available for third-party representatives from medical device repair service MERA to perform the upgrade. Last week, the FDA handed down another Class I label for that update to the recall.
The second Class I rating is part of LivaNova’s “agreed-upon strategy with the FDA,” according to the company’s statement to Fierce Medtech. It was issued essentially as an alert to ensure all users of the LifeSparc pumps undergo the software update; as of a Jan. 19 update on its website, the company is “nearing 100% completion” for the update process.
Additionally, the latest notice from the FDA notes that the recall now comprises 589 controllers distributed in the U.S. between December 2019 and November of last year.