Recall Z-0132-2025— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2024-08-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Vanta Implantable Neurostimulator (INS), Model 977006. Reason: Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-21
- Firm location
- Minneapolis, MN, United States
Product description
Vanta Implantable Neurostimulator (INS), Model 977006
Reason for recall
Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
Data sourced from openFDA. This site is unofficial and independent of the FDA.