Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; 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: 23223 units Lot/code info: GTIN 00643169720640, Lot Serial Numbers: RPB618471S, RPB621777S, RPB619798S, RPB622872S, RPB620883S, RPB621725S, RPB612828S, RPB605719S, RPB615701S, RPB605409S, RPB609214S, RPB619400S, RPB611888S, RPB603955S, RPB617094S, RPB610684S, RPB603737S, RPB603739S, RPB603852S, RPB603887S, RPB603889S, RPB603892S, RPB604013S, RPB604131S, RPB604133S, RPB604139S, RPB604469S, RPB604482S, RPB604483S, RPB604484S, RPB604496S, RPB604508S, RPB604545S, RPB604692S, RPB604694S, RPB604731S, RPB605760S, RPB605763S, RPB605930S, RPB605982S, RPB606024S, RPB606084S, RPB606117S, RPB606124S, RPB606125S, RPB606136S, RPB606189S, RPB606190S, RPB606192S, RPB606492S, RPB606657S, RPB606773S, RPB606838S, RPB607008S, RPB607012S, RPB607049S, RPB607332S, RPB607709S, RPB607752S, RPB607793S, RPB607820S, RPB607825S, RPB607893S, RPB607897S, RPB607920S, RPB608192S, RPB608216S, RPB608222S, RPB608237S, RPB608293S, RPB608313S, RPB608351S, RPB608378S, RPB608498S, RPB608607S, RPB608621S, RPB608652S, RPB608696S, RPB608839S, RPB608867S, RPB609639S, RPB609652S, RPB609969S, RPB610019S, RPB610077S, RPB610186S, RPB610230S, RPB610431S, RPB610434S, RPB610437S, RPB610506S, RPB610813S, RPB610882S, RPB610955S, RPB611316S, RPB611327S, RPB611370S, RPB611482S, RPB611609S, RPB611651S, RPB611822S, RPB612129S, RPB612132S, RPB612533S, RPB612628S, RPB612917S, RPB612955S, RPB612965S, RPB613003S, RPB613214S, RPB613216S, RPB613537S, RPB613551S, RPB613616S, RPB613908S, RPB613910S, RPB613976S, RPB614145S, RPB614187S, RPB614232S, RPB614237S, RPB6142

UPC codes

00643169720640

Source

Official record: FDA (Device enforcement) ↗

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