Abbott Liberta RC Pulse Generator Unexpectedly Shuts Down Periodically
Abbott Liberta RC implantable pulse generators used for deep brain stimulation may unexpectedly turn off approximately every 50 days after activation, resulting in loss of therapy. Approximately 302 units have been recalled nationwide.
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: This is a Class II recall of an implanted device with a functional defect causing periodic unintended shutdown. While no illnesses or injuries have been reported to date, the unexpected loss of deep brain stimulation therapy represents a significant risk of harm, as these devices treat serious neurological conditions and therapy interruption can result in symptom recurrence and patient safety concerns.
Plain-English summary
Abbott Medical is recalling the Liberta RC Implantable Pulse Generator (IPG), model REF 62400, a device used to deliver deep brain stimulation therapy. Approximately 302 units with specific serial numbers have been affected and recalled.
The recalled devices have a defect that causes them to turn off unexpectedly approximately 50 days after activation. After the initial shutdown, this same malfunction recurs approximately every 50 days thereafter. When the device turns off, patients experience an interruption in their stimulation therapy, resulting in a loss of the therapeutic benefits the device is designed to provide.
The affected units were distributed nationwide across the United States. Patients who have received this device should contact their healthcare provider immediately to determine if their specific unit is among those recalled by checking the serial number. Do not attempt to repair or modify the device yourself. Your healthcare provider will advise you on appropriate management options based on your individual clinical situation.
The recalled product
- Product
- Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
- Manufacturer
- Abbott Medical
- Hazard
- unintended-shutdown
- therapy-loss
Distribution
Distributed nationwide across the United States.
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