CanadaThe Eterna™ implantable pulse generator (spinal cord stimulation IPG), model 32400, by Abbott Medical — identified by lot or serial numbers with more than 10 digits — is affected. These IPGs may experience loss of communication with the clinician programmer and/or the patient controller due to a Bluetooth Low Energy circuit component manufacturing issue; contact the manufacturer for additional information.
What's being recalled
Companies: Abbott Medical, 6901 Preston Road, Plano, Texas, United States, 75024.
How to identify it
Affected products: Eterna™ Implantable Pulse Generator; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 32400
The hazard
Abbott is notifying customers of a potential issue affecting Eterna™ spinal cord stimulation (SCS) implantable pulse generators (IPGs), Model 32400. These IPGs may experience a loss of communication with the clinician programmer (CP) and/or the patient controller (PC). This issue has been traced to Bluetooth® low energy (BLE) circuit component manufacturing.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States