Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Reported: July 10, 2024 Initiated: May 16, 2024 #Z-2265-2024
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.
Details
- Recalling Firm
- Abbott Medical
- Units Affected
- 302 units
- Distribution
- US: Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NE, NH, NJ, NY, OH OK, OR, PA, SC, SD, TX, UT, WI, WV.
- Location
- Plano, TX
Frequently Asked Questions
What product was recalled? ▼
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY. Recalled by Abbott Medical. Units affected: 302 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2024. Severity: Moderate. Recall number: Z-2265-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11