Recall Z-1123-2022— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2022-03-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.. Reason: The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-30
- Firm location
- Minneapolis, MN, United States
Product description
Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
Reason for recall
The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.