Recall Monitor
Health Products

Eterna™ Implantable Pulse Generator

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: Eterna™ Implantable Pulse Generator
Issue: Medical devices - Device compatibility, Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Eterna™ Implantable Pulse GeneratorMore than 10 numbers, contact manufacturer.32400

Issue

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.

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