FDA (Devices) recall action 90530
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
St. Jude Medical recalled Merlin 2 PCS MER3400 programmer software version 1.1.2 revision 1 or earlier in an FDA Class II recall. The recall affects 622 units distributed across the United States and internationally.
St. Jude Medical's Merlin PCS 3650 programmer software may display overestimated predicted battery longevity for certain pacemakers. This could affect clinical decision-making regarding device maintenance and replacement timing.
St. Jude Medical recalls Merlin 2 PCS model MER3700, software used to program and interrogate Abbott implantable medical devices.