Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; 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: 2018 Units Lot/code info: GTIN 00763000178437, Lot Serial Numbers: RSQ600736S, RSQ600745S, RSQ600905S, RSQ600975S, RSQ601406S, RSQ600113S, RSQ600114S, RSQ600115S, RSQ600255S, RSQ600256S, RSQ600257S, RSQ600258S, RSQ600261S, RSQ600740S, RSQ601122S, RSQ601137S, RSQ601177S, RSQ601178S, RSQ601179S, RSQ601181S, RSQ601227S, RSQ601228S, RSQ601229S, RSQ601375S, RSQ601377S, RSQ600055S, RSQ600163S, RSQ600164S, RSQ600936S, RSQ601151S, RSQ600049S, RSQ600051S, RSQ600713S, RSQ600991S, RSQ601411S, RSQ601416S, RSQ600218S, RSQ600237S, RSQ600679S, RSQ600712S, RSQ600723S, RSQ600772S, RSQ600074S, RSQ600090S, RSQ600012S, RSQ600053S, RSQ600811S, RSQ600843S, RSQ600912S, RSQ600913S, RSQ600195S, RSQ600894S, RSQ600981S, RSQ600748S, RSQ601201S, RSQ601378S, RSQ601479S, RSQ601490S, RSQ600782S, RSQ600665S, RSQ600091S, RSQ600105S, RSQ600106S, RSQ600130S, RSQ600174S, RSQ600183S, RSQ600185S, RSQ600216S, RSQ600767S, RSQ600788S, RSQ600799S, RSQ601445S, RSQ601447S, RSQ601448S, RSQ601451S, RSQ601452S, RSQ600704S, RSQ600743S, RSQ600773S, RSQ600808S, RSQ600262S, RSQ602018S, RSQ600101S, RSQ600738S, RSQ600093S, RSQ600125S, RSQ600128S, RSQ600140S, RSQ600678S, RSQ600694S, RSQ600737S, RSQ600744S, RSQ600750S, RSQ600753S, RSQ600754S, RSQ600780S, RSQ600789S, RSQ600807S, RSQ600829S, RSQ600906S, RSQ600931S, RSQ601212S, RSQ601413S, RSQ600097S, RSQ600232S, RSQ600233S, RSQ600247S, RSQ600705S, RSQ600719S, RSQ600721S, RSQ600751S, RSQ600752S, RSQ600812S, RSQ600821S, RSQ600858S, RSQ600859S, RSQ600896S, RSQ600897S, RSQ600915S, RSQ600939S, RSQ600986S, RSQ6009

UPC codes

00763000178437, 00763000178444

Source

Official record: FDA (Device enforcement) ↗

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