Medical device recalls Moderate risk

Medtronic Neuromodulation recalls Vanta Implantable Neurostimulator (INS), Model 977006

Recall date
August 21, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0132-2025
FDA classification
Class II
Brand / firm
Medtronic Neuromodulation
Sold / distributed
Worldwide distribution.

Why it was recalled

Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vanta Implantable Neurostimulator (INS), Model 977006

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