Proclaim Plus 7 Implantable Pulse Generator recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product

Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be…

Recalling firm

Abbott Medical

Quantity

387 devices (US only)

Distribution

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.

Recall date

September 20, 2023

Classification

Class I

Status

Ongoing

Agency

FDA (device)