FDA (Devices) recall action 81949
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.
The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values ba…
There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).
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 to ensure they are used only for Medtronic or Vitatron implantable devices by trained personnel.
Medtronic is recalling CareLink 2090 programmers because they may incorrectly display the remaining longevity value for up to two years before the device reaches its Recommended Replacement Time.