Abbott recalls heart device monitoring system due to malfunction risk
Abbott has issued a new recall for its Merlin PCS 3650 device due to a significant software malfunction. No devices need to be returned to the manufacturer; installing a software update should resolve any potential issues.
The Merlin PCS 3650 is a portable system used to interrogate, monitor and program implantable cardiac devices during the initial implant as well as any follow-up appointments. It includes a touch screen for displaying programming details and diagnostic information. The technology’s design is quite similar to the more modern Merlin 2 PCS system.
The recall was put in place due to a risk of the intermittent loss of telemetry during the pacing capture threshold test for one of Abbott’s Aveir leadless pacemakers. More than 11,000 Merlin PCS 3650 devices with model 3330 software are affected by this recall. These systems were distributed throughout the United States.
According to Abbott, installing the new software update addresses this issue. Representatives from the company are working to contact customers and help them secure this update.
The U.S. Food and Drug Administration (FDA) has now shared details about this issue, categorizing it as a Class II recall. The agency noted that the malfunction, if not addressed, could result in the system “not successfully communicating the command to terminate the test.”
Click here for more information from the FDA.
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.