FDA finalizes recall due to heart devices sending delayed alerts—software update on the way
Boston Scientific is warning clinicians about an ongoing safety concern with its LUX-Dx family of insertable cardiac monitors (ICMs).
The U.S. Food and Drug Administration (FDA) has classified the issue as a Class II recall. No patient injuries have been reported at this time.
According to Boston Scientific, no devices need to be returned or replaced. However, there are steps users can take to address the issue until it can be properly fixed.
Key details about the LUX-Dx issue
These LUX-Dx ICMs are used to track patients for signs of atrial fibrillation and other arrhythmias. However, Boston Scientific has identified an issue with AF Burden Alerts not being sent to clinicians as intended. These alerts are managed by the company’s Latitude Clarity Data Management System. An update to that software is already being planned that will correct the issue.
“The most common outcome associated with a delayed clinician notification of the AF Burden Alert is no patient harm,” according to an Urgent Medical Device Correction from Boston Scientific. “While delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia, no patient injuries or deaths have been reported, and the most serious clinical consequences for untreated atrial arrhythmias remain hypothetical.”
The company also emphasized that the LUX-Dx devices are still storing alerts like normal. Alerts are just being delayed until the next full device interrogation, which may not occur until the patient’s next scheduled follow-up visit with a clinician. In addition, the AF Event Alerts associated with these devices are still functioning like normal with no delays.
What should customers do?
Boston Scientific is recommending that no devices be replaced at this time. Instead, as a temporary fix until the software update is finalized, users can configure the AF Burden Alert threshold to any setting other than “>0 hours per day” to minimize the risk of delays. Boston Scientific also urged users to change the duration setting for AF Events Alerts to 2 minutes.
“Boston Scientific is committed to providing high-quality products and appreciates your partnership in caring for patients,” according to the Urgent Medical Device Correction. “We apologize for any inconvenience this may cause.”
Heart Rhythm Society shares its perspective
The Heart Rhythm Society (HRS) has published its own recommendations for any clinicians impacted by these alert delays. The group agreed with Boston Scientific that no devices should be replaced at this time. It also encouraged members to review the situation and “discuss possible programming options” with Boston Scientific representatives as needed.
Click here for more details from the FDA. Click here for the HRS advisory.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.