Recall Z-2265-2024— Abbott Medical
Class II · Ongoing
Class II FDA medical device recall by Abbott Medical, initiated 2024-05-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY. Reason: Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy..
- Recalling firm
- Abbott Medical
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-16
- Firm location
- Plano, TX, United States
Product description
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Reason for recall
Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.