Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; 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: 37,547 units Lot/code info: GTIN 00643169720527, Lot Serial Numbers: PHZ203294H, PHZ204099H, PHZ202880H, PHZ202731H, PHZ203576H, PHZ203873H, PHZ202558H, PHZ202949H, PHZ203163H, PHZ204430H, PHZ203645H, PHZ204171H, PHZ204583H, PHZ204585H, PHZ204589H, PHZ204600H, PHZ204629H, PHZ204676H, PHZ204879H, PHZ204932H, PHZ204991H, PHZ205067H, PHZ205076H, PHZ205168H, PHZ205219H, PHZ205254H, PHZ205303H, PHZ204750H, PHZ202687H, PHZ203913H, PHZ203379H, PHZ203419H, PHZ203421H, PHZ203422H, PHZ203423H, PHZ203425H, PHZ203426H, PHZ203427H, PHZ203435H, PHZ203798H, PHZ203805H, PHZ203808H, PHZ203809H, PHZ203811H, PHZ203816H, PHZ203819H, PHZ203820H, PHZ203822H, PHZ203828H, PHZ203829H, PHZ203830H, PHZ203831H, PHZ204440H, PHZ204442H, PHZ204444H, PHZ204445H, PHZ204446H, PHZ204447H, PHZ204448H, PHZ204449H, PHZ204451H, PHZ205205H, PHZ205206H, PHZ205207H, PHZ205208H, PHZ205209H, PHZ205210H, PHZ205211H, PHZ205213H, PHZ205216H, PHZ205244H, PHZ202741H, PHZ203347H, PHZ202606H, PHZ202985H, PHZ203618H, PHZ204288H, PHZ205146H, PHZ202758H, PHZ202806H, PHZ203203H, PHZ203252H, PHZ203313H, PHZ203319H, PHZ203321H, PHZ203702H, PHZ203771H, PHZ204242H, PHZ204399H, PHZ204603H, PHZ204771H, PHZ204983H, PHZ204987H, PHZ205118H, PHZ205301H, PHZ205302H, PHZ202654H, PHZ202763H, PHZ202764H, PHZ203019H, PHZ203220H, PHZ203333H, PHZ203420H, PHZ203573H, PHZ204247H, PHZ204394H, PHZ204534H, PHZ204747H, PHZ204878H, PHZ204962H, PHZ205396H, PHZ202796H, PHZ202886H, PHZ203577H, PHZ203611H, PHZ202965H, PHZ203867H, PHZ205448H, PHZ204468H, PHZ203789H, PHZ203249H, PHZ2036

UPC codes

00643169720527, 00643169720534

Source

Official record: FDA (Device enforcement) ↗

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