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FDAFebruary 4, 2020device

VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.

What to do

FDA enforcement status: Ongoing

Brands named

livanova

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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