FDA (Devices) recall action 81300
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.
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.
Medtronic is recalling CareLink Encore 29901 Programmers worldwide due to a vulnerability that allows unauthorized software updates during SDN downloads.
Medtronic is recalling CareLink 2090 Programmers worldwide due to a vulnerability that allows unauthorized software updates during the SDN download process.