01
Apr
2020

Recall – VNS Therapy Programmer displays false positive under certain conditions

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0

Company: LivaNova USA Inc
Date of Enforcement Report: 4/1/2020
Class II

PRODUCT

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

  • Recall Number: Z-1563-2020

REASON

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.

RECALLING FIRM/MANUFACTURER

LivaNova USA Inc on 2/4/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

2683

DISTRIBUTION

US Nationwide and International

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