Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; 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: 2968 units Lot/code info: GTIN 00763000178215, Lot Serial Numbers: RTO600161S, RTO600247S, RTO601140S, RTO601641S, RTO602045S, RTO602335S, RTO602270S, RTO600314S, RTO601040S, RTO601383S, RTO600175S, RTO600229S, RTO600417S, RTO600458S, RTO600507S, RTO600650S, RTO601039S, RTO602060S, RTO603798S, RTO600463S, RTO601433S, RTO601826S, RTO601973S, RTO602476S, RTO601038S, RTO601148S, RTO601171S, RTO601248S, RTO602261S, RTO601481S, RTO600833S, RTO601285S, RTO601310S, RTO601556S, RTO600393S, RTO602484S, RTO600262S, RTO600681S, RTO601538S, RTO600380S, RTO600384S, RTO601944S, RTO602394S, RTO602445S, RTO600968S, RTO601037S, RTO601565S, RTO600218S, RTO601309S, RTO601311S, RTO601453S, RTO603333S, RTO600332S, RTO600493S, RTO601704S, RTO601798S, RTO601954S, RTO601983S, RTO602442S, RTO601808S, RTO601986S, RTO602037S, RTO600385S, RTO600435S, RTO601216S, RTO601220S, RTO601630S, RTO601735S, RTO601244S, RTO601307S, RTO601308S, RTO601043S, RTO602304S, RTO600445S, RTO600450S, RTO601513S, RTO601618S, RTO601942S, RTO600251S, RTO601520S, RTO600716S, RTO600464S, RTO601650S, RTO600151S, RTO600363S, RTO601008S, RTO600267S, RTO600268S, RTO600571S, RTO600605S, RTO600640S, RTO602065S, RTO600244S, RTO600634S, RTO602301S, RTO602309S, RTO600283S, RTO601834S, RTO602047S, RTO602593S, RTO601959S, RTO601109S, RTO601586S, RTO602128S, RTO602485S, RTO602486S, RTO602542S, RTO602121S, RTO600657S, RTO600729S, RTO600730S, RTO600731S, RTO601325S, RTO601490S, RTO601491S, RTO601493S, RTO601558S, RTO601560S, RTO601561S, RTO601562S, RTO601049S, RTO6011

UPC codes

00763000178215, 00763000178239

Source

Official record: FDA (Device enforcement) ↗

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