Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; 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: 10,903 units Lot/code info: GTIN 00643169837737, Lot Serial Numbers: CWC602314S, CWC602130S, CWC601890S, CWC607466S, CWC602236S, CWC602359S, CWC608108S, CWC607103S, CWC601544S, CWC601546S, CWC605273S, CWC602965S, CWC604941S, CWC605039S, CWC601687S, CWC601688S, CWC602560S, CWC602845S, CWC603176S, CWC603372S, CWC603584S, CWC603596S, CWC603780S, CWC603826S, CWC603862S, CWC604054S, CWC604145S, CWC604909S, CWC605061S, CWC605800S, CWC607271S, CWC607272S, CWC607475S, CWC608775S, CWC608917S, CWC608956S, CWC608480S, CWC608488S, CWC603831S, CWC604086S, CWC604166S, CWC604240S, CWC604391S, CWC604670S, CWC604681S, CWC604684S, CWC604846S, CWC604847S, CWC605090S, CWC605290S, CWC605410S, CWC605411S, CWC605588S, CWC605600S, CWC605863S, CWC605864S, CWC605867S, CWC605876S, CWC605988S, CWC605989S, CWC606354S, CWC606357S, CWC606358S, CWC606521S, CWC606523S, CWC606525S, CWC606527S, CWC606528S, CWC606529S, CWC606531S, CWC606939S, CWC606942S, CWC607001S, CWC607022S, CWC607619S, CWC607630S, CWC607631S, CWC607635S, CWC604643S, CWC605193S, CWC605519S, CWC605785S, CWC606634S, CWC606664S, CWC606904S, CWC606912S, CWC607065S, CWC605675S, CWC605681S, CWC606623S, CWC606625S, CWC606627S, CWC606630S, CWC606675S, CWC606903S, CWC606905S, CWC606907S, CWC606622S, CWC602509S, CWC602834S, CWC602842S, CWC602870S, CWC602894S, CWC603092S, CWC603787S, CWC606427S, CWC606910S, CWC607057S, CWC607062S, CWC607063S, CWC607068S, CWC607070S, CWC607078S, CWC607079S, CWC607566S, CWC607748S, CWC607752S, CWC601658S, CWC602650S, CWC602956S, CWC603748S, CWC6084

UPC codes

00643169837737

Source

Official record: FDA (Device enforcement) ↗

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