Medtronic Vanta Neurostimulator Recall for Premature Battery Depletion
Medtronic is recalling Vanta Implantable Neurostimulators (Model 977006) because battery life depleted faster than expected, leading to earlier surgical replacements or reprogramming.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (implantable device) where the defect leads to earlier surgical intervention, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Medtronic Neuromodulation is recalling 11,789 units of the Vanta Implantable Neurostimulator (INS), Model 977006. The recall was initiated because the battery life of these devices has depleted faster than healthcare providers or patients expected.
This issue has led to outpatient reprogramming or surgical replacements occurring earlier than anticipated. The affected devices were distributed worldwide.
Patients with this specific model should contact their healthcare provider to discuss the recall and determine if their device requires monitoring or intervention. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Vanta Implantable Neurostimulator (INS), Model 977006
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 11,789
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 00763000411923
- Serial Numbers: NMS500122H
- NMS500123H
- NMS500130H
- NMS500135H
- NMS500159H
- NMS500190H
- NMS500191H
- NMS500194H
- NMS500201H
- NMS500309H
- NMS500310H
- NMS500312H
- NMS500313H
- NMS500314H
- NMS500315H
- NMS500316H
- NMS500317H
- NMS500318H
- NMS500319H
Distribution
Distribution scope not specified by the agency.
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