Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators

Hazard

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Details from the source

Reason for recall: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds. Distribution: US Nationwide - Worldwide Distribution Quantity: 1878 units Lot/code info: GTIN 00763000178185, Lot Serial Numbers: RTL600234S, RTL600470S, RTL601046S, RTL601412S, RTL601722S, RTL601669S, RTL601698S, RTL600323S, RTL600660S, RTL600661S, RTL601185S, RTL601206S, RTL601213S, RTL601406S, RTL601445S, RTL601446S, RTL600649S, RTL600650S, RTL601428S, RTL601017S, RTL600219S, RTL601076S, RTL601544S, RTL602514S, RTL600684S, RTL601477S, RTL601865S, RTL600638S, RTL600639S, RTL600640S, RTL600641S, RTL600642S, RTL600643S, RTL601151S, RTL601154S, RTL601156S, RTL601160S, RTL601161S, RTL601162S, RTL601163S, RTL601164S, RTL601165S, RTL601167S, RTL601170S, RTL600209S, RTL600835S, RTL600997S, RTL600519S, RTL601459S, RTL601689S, RTL600978S, RTL601540S, RTL601880S, RTL600522S, RTL601510S, RTL600949S, RTL601624S, RTL601372S, RTL600810S, RTL600266S, RTL600281S, RTL600528S, RTL600596S, RTL600654S, RTL600777S, RTL600813S, RTL600841S, RTL600846S, RTL601563S, RTL601021S, RTL601208S, RTL600243S, RTL600244S, RTL600245S, RTL600533S, RTL601085S, RTL601148S, RTL601373S, RTL601231S, RTL601864S, RTL601607S, RTL600270S, RTL600499S, RTL600755S, RTL601441S, RTL601475S, RTL601575S, RTL601804S, RTL601278S, RTL600794S, RTL600844S, RTL601143S, RTL601144S, RTL600960S, RTL601470S, RTL601082S, RTL601289S, RTL601291S, RTL601584S, RTL601660S, RTL601933S, RTL601964S, RTL600333S, RTL600454S, RTL600483S, RTL600591S, RTL600606S, RTL600658S, RTL600735S, RTL600959S, RTL601589S, RTL601792S, RTL601824S, RTL600418S, RTL600659S, RTL600690S, RTL601482S, RTL601490S, RTL601530S, RTL601592S, RTL601595S, RTL6016

UPC codes

00763000178185, 00763000178208

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.