Recall Z-0462-2021— LivaNova USA Inc
Class II · Terminated
Class II FDA medical device recall by LivaNova USA Inc, initiated 2020-09-28, terminated 2022-11-02. FDA's recall record names no specific 510(k) clearance for this event. Product: VNS Therapy¿ AspireSR¿ Generator. Reason: Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4..
- Recalling firm
- LivaNova USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-28
- Terminated
- 2022-11-02
- Firm location
- Houston, TX, United States
Product description
VNS Therapy¿ AspireSR¿ Generator
Reason for recall
Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.
Data sourced from openFDA. This site is unofficial and independent of the FDA.