FDA (Devices) recall action 91296
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
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 recalls the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies generating error messages that may affect device operation. The recall affects 22 units distributed worldwide.
Medtronic Neuromodulation is recalling 440 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that interfere with device control. Affected units were distributed worldwide.
Medtronic is recalling 362 units of the Vanta/Seqenita LT Clinician Programmer Application due to software anomalies that display error messages affecting pain therapy neurostimulation system programmer functionality.
Medtronic is recalling 18 units of its Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that may prevent proper operation.
Medtronic is recalling 1,337 Vanta Seqenita LT neurostimulation programmer units worldwide due to software anomalies that generate specific error messages in the clinician application.