Recall Z-0458-2026 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Abbott Medical
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
| Date | Nov 7, 2025 (initiated Oct 6, 2025) |
| Status | Open, Classified |
| Reason | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC). |
| Root cause | Process control |
| Action | On 10/01/2025 Abbott issued an URGENT MEDCIAL DEVICE RECALL NOTICE to its consignees via email and mail. The notice explained the issue and requested the devices not be implanted, and informed the consignee that a representative would remove the affected devices. Abbott issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 10/06/2025 via email and mail using a traceable means. The notice explained the issued and provided the following patient management guidance: "There are various factors that can lead to BLE communication loss between an IPG and CP/PC, and not all inst |
| Quantity | 20715 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.