CLASS II ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report

Liberta RC DBS IPG (Implantable Pulse Generator) recalled

Abbott Medical is recalling Liberta RC DBS IPG (Implantable Pulse Generator). The recall was initiated on 6 Oct 2025 and the FDA has classified it as Class II.

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Lot, batch or date codesUDI/DI 05415067047663, Serial Numbers: 20196493, 20196495, 20196496, 20196497, 20196498, 20196500, 20196502, 20196503, 20196504, 20196505, 20196506, 20196507, 20196508, 20196509, 20196511, 20196512, 20196513, 20196514, 20196515, 20196516, 20196517, 20207397, 20207398, 20207399, 20207400, 20207401, 20207402, 20207403, 20207405, 20207406, 20207407, 20207408, 20207409, 20207410, 20207411, 20207412, 20207413, 20207414, 20207415, 20207416, 20207417, 20207418, 20207419, 20207420, 20207421, 20207422, 20207423, 20207424, 20207425, 20207427, 20207428, 20207429, 20207430, 20207431, 20207432, 20207433, 20207434, 20207435, 20207436, 20207437, 20207438, 20207441, 20207442, 20207443, 20207444, 20207445, 20207446, 20207447, 20207448, 20207449, 20207450, 20207451, 20207452, 20207454, 20207455, 20207456, 20207457, 20207458, 20207459, 20207460, 20207461, 20207462, 20207463, 20207464, 20207465, 20207466, 20207467, 20207468, 20207469, 20207470, 20207471, 20207472, 20207473, 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Quantity recalled722 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0459-2026
FDA event ID: 97754
Recalling firm: Abbott Medical, Plano, TX
Classification: Class II
Status: Ongoing
Recall initiated: 6 Oct 2025
FDA classified: 7 Nov 2025
Reported: 19 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Oct 2025	Recall initiated by company
7 Nov 2025	Classified by FDA	+32 days
19 Nov 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Product as listed by the FDA

Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

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Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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