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