Medtronic Neuromodulation recalls
5 recalls on record · FDA
Every recall we have on record for Medtronic Neuromodulation, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Restore Clinician Programmer Application (CP App), Model A71100 used with the following…
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
SynchroMed II Infusion Pump. Product Number: 8637-20
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain…
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim…
The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.