Recall Z-1574-2022— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2022-07-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.. Reason: Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-07-26
- Firm location
- Minneapolis, MN, United States
Product description
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Reason for recall
Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator.
Data sourced from openFDA. This site is unofficial and independent of the FDA.