Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; 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: 8219 units Lot/code info: GTIN 00763000001582, Lot Serial Numbers: CWT605432S, CWT600264S, CWT607420S, CWT607213S, CWT607463S, CWT607388S, CWT607425S, CWT607374S, CWT607359S, CWT601622S, CWT603529S, CWT605876S, CWT605723S, CWT604657S, CWT604666S, CWT605105S, CWT605034S, CWT608381S, CWT608194S, CWT606083S, CWT604306S, CWT606483S, CWT607258S, CWT606731S, CWT605978S, CWT607015S, CWT606443S, CWT607932S, CWT608011S, CWT607139S, CWT606486S, CWT605678S, CWT607017S, CWT607943S, CWT608012S, CWT606735S, CWT606736S, CWT606738S, CWT606739S, CWT606741S, CWT606742S, CWT606743S, CWT606744S, CWT606745S, CWT606746S, CWT606747S, CWT606748S, CWT606749S, CWT606750S, CWT603376S, CWT607308S, CWT602883S, CWT603530S, CWT604069S, CWT604509S, CWT604647S, CWT604878S, CWT605689S, CWT605944S, CWT606036S, CWT600803S, CWT601014S, CWT601028S, CWT601179S, CWT601231S, CWT601422S, CWT602980S, CWT602981S, CWT603019S, CWT603216S, CWT603319S, CWT603320S, CWT604576S, CWT605154S, CWT600275S, CWT601002S, CWT601180S, CWT601388S, CWT601407S, CWT601417S, CWT601516S, CWT601527S, CWT601652S, CWT601681S, CWT601719S, CWT601946S, CWT602082S, CWT602826S, CWT602908S, CWT602909S, CWT603061S, CWT603503S, CWT603506S, CWT603642S, CWT604058S, CWT604226S, CWT604247S, CWT604526S, CWT604690S, CWT604887S, CWT605146S, CWT605366S, CWT605914S, CWT605945S, CWT605947S, CWT606707S, CWT606841S, CWT607734S, CWT607765S, CWT606600S, CWT606712S, CWT608010S, CWT603422S, CWT603615S, CWT604547S, CWT600386S, CWT601108S, CWT601852S, CWT600660S, CWT600729S, CWT601033S, CWT6016

UPC codes

00763000001582

Source

Official record: FDA (Device enforcement) ↗

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