Recall Z-0458-2026— Abbott Medical
Class II · Ongoing
Class II FDA medical device recall by Abbott Medical, initiated 2025-10-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400. 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)..
- Recalling firm
- Abbott Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-06
- Firm location
- Plano, TX, United States
Product description
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Reason for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.