Recall Z-2265-2024 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Abbott Medical
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
| Date | Jul 3, 2024 (initiated May 16, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | On May 16, 2024 and May 24, 2024, Abbott issued a "Urgent Medical Device Recall" notification to affected consignees informing them to discontinue implanting affected devices and returned affected devices. On August 8, 2024, Abbott issued a "Urgent Medical Device Recall update (Update)" notification informing consignees that a system update was available to correct the issue with Liberta RC" DBS System stimulation turning off at approximately 50-day intervals. . Abbott asked consignees to take the following actions: 1. What to expect during your appointment: "Your Patient Controller appli |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.