Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; 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: 510 units Lot/code info: GTIN 00763000178536, Lot Serial Numbers: RSG600215S, RSG600106S, RSG600196S, RSG600208S, RSG600223S, RSG600280S, RSG600125S, RSG600193S, RSG600006S, RSG600016S, RSG600123S, RSG600136S, RSG600573S, RSG600113S, RSG600249S, RSG600395S, RSG600579S, RSG600173S, RSG600111S, RSG600112S, RSG600116S, RSG600118S, RSG600130S, RSG600143S, RSG600175S, RSG600191S, RSG600205S, RSG600209S, RSG600272S, RSG600564S, RSG600167S, RSG600187S, RSG600077S, RSG600131S, RSG600145S, RSG600162S, RSG600245S, RSG600253S, RSG600512S, RSG600519S, RSG600037S, RSG600536S, RSG600544S, RSG600210S, RSG600643S, RSG600642S, RSG600122S, RSG600138S, RSG600174S, RSG600200S, RSG600225S, RSG600233S, RSG600585S, RSG600134S, RSG600168S, RSG600148S, RSG600132S, RSG600240S, RSG600055S, RSG600121S, RSG600179S, RSG600186S, RSG600158S, RSG600181S, RSG600219S, RSG600108S, RSG600164S, RSG600255S, RSG600511S, RSG600109S, RSG600110S, RSG600115S, RSG600117S, RSG600178S, RSG600250S, RSG600560S, RSG600083S, RSG600581S, RSG600639S, RSG600140S, RSG600232S, RSG600126S, RSG600141S, RSG600152S, RSG600166S, RSG600183S, RSG600204S, RSG600228S, RSG600242S, RSG600243S, RSG600246S, RSG600278S, RSG600114S, RSG600190S, RSG600201S, RSG600137S, RSG600157S, RSG600172S, RSG600171S, RSG600537S, RSG600185S, RSG600163S, RSG600546S, RSG600231S, RSG600144S, RSG600220S, RSG600107S, RSG600237S, RSG600554S, RSG600119S, RSG600520S, RSG600625S, RSG600627S; GTIN 00763000178543, Lot Serial Numbers: RSG600567S, RSG600684S, RSG600753S, RSG600654S, RSG600347S, RS

UPC codes

00763000178536, 00763000178543

Source

Official record: FDA (Device enforcement) ↗

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