Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; 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: 31884 units Lot/code info: GTIN 00643169720688, Lot Serial numbers: RPF622750S, RPF618290S, RPF616459S, RPF619209S, RPF620414S, RPF613519S, RPF617908S, RPF607263S, RPF605123S, RPF606355S, RPF607965S, RPF607966S, RPF607968S, RPF607969S, RPF610837S, RPF612639S, RPF613175S, RPF613176S, RPF614678S, RPF616130S, RPF616164S, RPF616174S, RPF616577S, RPF616578S, RPF617220S, RPF617584S, RPF617585S, RPF617586S, RPF619084S, RPF619475S, RPF619476S, RPF619729S, RPF609798S, RPF609803S, RPF609809S, RPF610924S, RPF610929S, RPF610935S, RPF610938S, RPF610947S, RPF614776S, RPF614782S, RPF618353S, RPF618354S, RPF618355S, RPF618356S, RPF618357S, RPF618358S, RPF618361S, RPF618362S, RPF608224S, RPF608225S, RPF611060S, RPF614821S, RPF616957S, RPF617031S, RPF618423S, RPF618476S, RPF619798S, RPF620332S, RPF621332S, RPF622094S, RPF620132S, RPF621989S, RPF615594S, RPF615595S, RPF620714S, RPF623023S, RPF612794S, RPF612795S, RPF612796S, RPF612799S, RPF612800S, RPF612801S, RPF612802S, RPF612829S, RPF612831S, RPF612833S, RPF613375S, RPF613376S, RPF613377S, RPF613378S, RPF613422S, RPF613858S, RPF613859S, RPF613860S, RPF613861S, RPF613862S, RPF613864S, RPF613865S, RPF613866S, RPF613867S, RPF613868S, RPF613869S, RPF613870S, RPF613874S, RPF613876S, RPF613881S, RPF613885S, RPF613887S, RPF614969S, RPF615082S, RPF615086S, RPF615260S, RPF615261S, RPF615268S, RPF615269S, RPF615273S, RPF615274S, RPF615275S, RPF615661S, RPF615676S, RPF615705S, RPF615710S, RPF615720S, RPF615724S, RPF615732S, RPF616201S, RPF616631S, RPF616709S, RPF617985S, RPF6179

UPC codes

00643169720688

Source

Official record: FDA (Device enforcement) ↗

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