Abbott Medical: Medical Device Recall in 2023 - (Recall #: Z-2508-2023)

Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Class I

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

Model Number: 3672 UDI-DI Codes: 05415067046406 Serial Numbers: US CBW328.1 CCA167.1 CCA177.1 CCU613.1 CCV760.1 CCX700.1 CCY890.1 CDR307.1 CDW220.1 CEC548.1 CEC719.1 CEE095.1 CEH111.1 CEH156.1 CEH200.1 CEH272.1 CEH293.1 CEH334.1 CEH964.1 CEH975.1 CEH993.1 CEK127.1 CEK258.1 CEK265.1 CEK271.1 CEK310.1 CEK432.1 CEM232.1 CEM340.1 CEM349.1 CEM375.1 CEM383.1 CEM396.1 CEN429.1 CEN444.1 CEP494.1 CEP497.1 CEP537.1 CEP540.1 CEP541.1 CEP553.1 CEP554.1 CEP562.1 CEP585.1 CEP645.1 CEP658.1 CEP663.1 CEP671.1 CEP685.1 CEP725.1 CEP730.1 CEP838.1 CEP847.1 CEP867.1 CER393.1 CER395.1 CER462.1 CER482.1 CER509.1 CER576.1 CET134.1 CET147.1 CET298.1 CET336.1 CET343.1 CET649.1 CEY608.1 CEY648.1 CFL299.1 CFL403.1 CFL540.1 CFL582.1 CFP963.1 CFP987.1 CFP991.1 CFR079.1 CFR100.1 CFR121.1 CFR392.1 CFR446.1 CFR478.1 CFR585.1 CFU079.1 CFU082.1 CFU091.1 CFU097.1 CFU098.1 CFU099.1 CFU121.1 CFU126.1 CFU132.1 CFU145.1 CFU333.1 CFU401.1 CFU426.1 CFU441.1 CFU460.1 CFU467.1 CFU472.1 CFU483.1 CFU526.1 CFU547.1 CFU569.1 CFU646.1 CFU687.1 CFV457.1 CFV588.1 CFV718.1 CFX211.1 CGA013.1 CGA029.1 CGA065.1 CGA097.1 CGA145.1 CGA331.1 CGA365.1 CGA406.1 CGA426.1 CGA451.1 CGA491.1 CGA500.1 CGA515.1 CGA581.1 CGC898.1 CGC908.1 CGC916.1 CGC921.1 CGC926.1 CGC955.1 CGC957.1 CGD063.1 CGD070.1 CGD076.1 CGD085.1 CGD101.1 CGD111.1 CGD119.1 CGD123.1 CGD192.1 CGD193.1 CGD220.1 CGD231.1 CGD240.1 CGD248.1 CGD251.1 CGD277.1 CGD278.1 CGD283.1 CGD308.1 CGD342.1 CGD343.1 CGD362.1 CGD694.1 CGD719.1 CGD739.1 CGD777.1 CGD790.1 CGD832.1 CGD892.1 CGG890.1 CGH131.1 CGH175.1 CGH183.1 CGH199.1 CGH245.1 CGH346.1 CGH413.1 CGL108.1 CGL207.1 CGL321.1 CGL863.1 CGL866.1 CGL889.1 CGP051.1 CGP078.1 CGP326.1 CGP615.1 CGS914.1 CGW231.1 CHB011.1 CHE598.1 CHE845.1 CHF161.1 CHF178.1 CHH717.1 CHH744.1 CHH773.1 CHJ032.1 CHK331.1 CHK354.1 CHK434.1 CHK648.1 CHM211.1 CHM389.1 CHM509.1 CHP603.1 CHP605.1 CHP621.1 CHR155.1 CHR240.1 CHT217.1 CHT238.1 CHT240.1 CHT241.1 CHT243.1 CHT245.1 CHT272.1 CHT356.1 CHT361.1 CHT373.1 CHT469.1 CHT478.1 CHT539.1 CHT553.1 CHT561.1 CHT589.1 CHT609.1 CHT624.1 CHT758.1 CHT815.1 CHT834.1 CHV674.1 CHV680.1 CHV710.1 CHV713.1 CHV794.1 CHV901.1 CHV989.1 CHW217.1 CHW262.1 CHW263.1 CHW306.1 CHW350.1 CHW362.1 CHW526.1 CHW560.1 CHW590.1 CHW591.1 CHW640.1 CHZ471.1 CHZ563.1 CHZ576.1 CJA246.1 CJG129.1 CJG177.1 CJM932.1 CJM940.1 CJN773.1 CJN780.1 CJN879.1 CJN987.1 CJP047.1 CJW418.1 CJW475.1 CJW534.1 CJW548.1 CJW586.1 CJX925.1 CJX962.1 CJX982.1 CJX986.1 CJY012.1 CJY075.1 CJY111.1 CJY226.1 CJY238.1 CJY304.1 CJY323.1 CJY360.1 CJY409.1 CJZ061.1 CJZ103.1 CJZ135.1 CJZ157.1 CJZ224.1 CJZ241.1 CJZ253.1 CJZ256.1 CJZ283.1 CJZ293.1 CJZ300.1 CJZ330.1 CJZ420.1 CJZ444.1 CJZ450.1 CKB402.1 CKB428.1 CKB439.1 CKB447.1 CKB487.1 CKB507.1 CKB608.1 CKB624.1 CKB654.1 CKB696.1 CKB725.1 CKB767.1 CKB887.1 CKD072.1 CKF569.1 CKF587.1 CKG394.1 CKG550.1 CKG586.1 CKG607.1 CKG915.1 CKG954.1 CKG956.1 CKG962.1 CKH467.1 CKH606.1 CKH692.1 CKH719.1 CKH736.1 CKH765.1 CKH774.1 CKH786.1 CKH815.1 CKH859.1 CKH923.1 CKL195.1 CKL217.1 CKL236.1 CKL295.1 CKL345.1 CKL464.1 CKL487.1 CKP251.1 CKP255.1 CKP277.1 CKP291.1 CKP393.1 CKP435.1 CKP483.1 CKP495.1 CKP563.1 CKP656.1 CKP678.1 CKP682.1 CKP717.1 CKP733.1 CKP803.1 CKP939.1 CKS483.1 CKS519.1 CKS531.1 CKS552.1 CKS588.1 CKS590.1 CKS616.1 CKS641.1 CKS662.1 CKS673.1 CKS684.1 CKS692.1 CKS698.1 CKS706.1 CKS827.1 CKS856.1 CKS869.1 CKS954.1 CKS986.1 CKS992.1 CKS994.1 CKS997.1 CKT159.1 CKY723.1 CKY781.1 CLC604.1 CLD150.1 CLD293.1 CLF739.1 CLF855.1 CLF880.1 CLF888.1 CLF901.1 CLG005.1 CLG094.1 CLG124.1 CLG391.1 CLG393.1 CLG395.1 CLG396.1 CLG423.1 CLG457.1 CLG534.1 CLK164.1

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.

Voluntary: Firm initiated