Recall Z-0462-2021 ยท LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
LivaNova USA Inc
VNS Therapy AspireSR Generator
| Date | Sep 28, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | On 09/28/2020, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter to customers via certified 1st class return receipt informing them of an incompatibility warning message will appear with the use of the VNS Therapy Programmers with software version 11.0.4 upon interrogation of certain generators (specifically serial numbers e 1,000,000). This software incompatibility issue is due to the use of a now discontinued 7-digit serial number, thereby resulting in an error in the serial number and causing a communication disruption. For certain generators (SN e 1,000,000) using so |
| Quantity | 134 generators |
| Distribution | U.S.: AK, AL, AZ, CA, CO, DC, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, NE, NV, OK, OR, PR, TX, UT, VA, and WA O.U.S.: Argentina, Finland and Peru |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.