Stryker (NYSE:SYK) said last Friday that it is launching a select voluntary recall of Lifepak 15 monitor/defibrillators over issues in which the device locks up and may not deliver life-saving therapy, adding that it has received six reports of deaths related to the issue.
The Kalamazoo, Mich.-based company said that an issue with the Lifepak 15 may cause the device to cease functioning after it delivers a defibrillation shock, displaying a blank monitor while keeping LED lights on to indicate the device is powered.
In this state, the device “has the potential to delay delivery of the therapy, and this delay in therapy has the potential to result in serious injury or death,” Stryker wrote in a press release.
The company said that it has received 58 complaints of the issue globally, including six patient deaths reported related to the malfunction. A total 13,003 devices are potentially affected by the issue.
Stryker said that it is reaching out to customers with affected devices to schedule for a device correction, which includes updated firmware for an internal component. The company said that it hopes to complete servicing all affected devices by the end of this year, and instructed customers experiencing the issue to contact it immediately.
Stryker said that individuals should use the systems normally until corrections can be completed, and added that automatic self-tests will not identify the fault as it occurs only during defibrillation.
Last week, Stryker saw shares rise after the medical device maker beat expectations on Wall Street with its fourth quarter and full fiscal year 2018 earnings.