Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
FDA Recall #Z-2265-2024 — Class II — May 16, 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.
Recalling Firm
Abbott Medical — Plano, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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.
Code Information
UDI-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 20207404 20207406 20207407 20207408 20207409 20207410 20207411 20207412 20207413 20207416 20207417 20207419 20207420 20207421 20207422 20207423 20207424 20207425 20207427 20207428 20207429 20207430 20207431 20207432 20207433 20207434 20207435 20207436 20207437 20207438 20207441 20207442 20207443 20207445 20207447 20207448 20207449 20207450 20207451 20207452 20207454 20207455 20207456 20207457 20207458 20207459 20207460 20207461 20207462 20207463 20207465 20207466 20207468 20207469 20207470 20207471 20207473 20207474 20207477 20207478 20207481 20207482 20207483 20207484 20207485 20207486 20207487 20207488 20207489 20207490 20207491 20207494 20207495 20208681 20208682 20208683 20208685 20208687 20208688 20208689 20208690 20208691 20208692 20208693 20208696 20208697 20208698 20208699 20208701 20208703 20208704 20219079 20219080 20219081 20219082 20219083 20219084 20219087 20219088 20219089 20219090 20219092 20219093 20219095 20219096 20219099 20219100 20219101 20219102 20219103 20219104 20219105 20219106 20219107 20219108 20219111 20219114 20219115 20219116 20219117 20219118 20219119 20219120 20219121 20219122 20219123 20219126 20219128 20219129 20219130 20219131 20219132 20219133 20219134 20219135 20219136 20219139 20219140 20219142 20219144 20219145 20219146 20219147 20219148 20219149 20219151 20219152 20219154 20219155 20219156 20219157 20219159 20219160 20219162 20219163 20219166 20219167 20219169 20219171 20219174 20219176 20219178 20232812 20232815 20232816 20232818 20232819 20232820 20232821 20232822 20232823 20232824 20232827 20232829 20232831 20232832 20232833 20232834 20232836 20232837 20232839 20232844 20232846 20232849 20232850 20232851 20232852 20232854 20232855 20232856 20232857 20232858 20232860 20232861 20232864 20232865 20232867 20232869 20232874 20232877 20232879 20232881 20237409 20237418 20237432 20237433 20237435 20237436 20237444 20237448 20237449 20237452 20237456 20237457 20237461 20237465 20237469 20237477 20237479 20237480 20237481 20237482 20237483 20237484 20237488 20237490 20237492 20237493 20237494 20237503 20240514 20240515 20240516 20240520 20240521 20240529 20240530 20240531 20240533 20240537 20240539 20240542 20240543 20240552 20232841 20232842 20240528 20237476 20237423 20237468 20237489 20266867 20237416 20237447 20208695 20240551 20237419 20237428 20232838 20232873 20232872 20237427 20237417 20237471 20219098 20219137 20240546 20237455 20237472 20237453 20237443 20237462 20237459 20237486
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.