Spinal cord stimulators recalled over loss of programmer communication
Abbott Medical is recalling 20,715 Eterna spinal cord stimulation implantable pulse generators because the devices may lose communication with the clinician programmer or patient controller.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: an implanted stimulator that cannot be reprogrammed or interrogated is a hazard, and no injuries are reported.
Plain-English summary
The Abbott Eterna SCS Implantable Pulse Generator, model 32400, is being recalled.
The firm has identified a potential issue affecting Eterna Spinal Cord Stimulation IPGs (model 32400) and Liberta RC Deep Brain Stimulation IPGs (model 62400). These devices may experience a loss of communication with the Clinician Programmer and/or the Patient Controller.
The recall covers 20,715 units carrying UDI/DI 05415067040763, distributed worldwide. The FDA has classified the action as Class II.
Losing the programming link means therapy settings cannot be adjusted or checked on an implanted device. The enforcement record reports no injuries. Patients and clinicians should follow Abbott's instructions.
The recalled product
- Product
- Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
- Manufacturer
- Abbott Medical
- Category
- Medical Device — Neurostimulator
- Hazard
- communication-loss
- implant
- programming-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 05415067040763
- Serial Numbers: 19400015
- 19400017
- 19400020
- 19400021
- 19400022
- 19400023
- 19400025
- 19400026
- 19400029
- 19400030
- 19400031
- 19400033
- 19400035
- 19400037
- 19400038
- 19400039
- 19400040
- 19400041
- 19400042
Distribution
Distribution scope not specified by the agency.
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