Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; 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: 8626 units Lot/code info: GTIN 00643169837720, Lot Serial Numbers: CWB609778S, CWB609784S, CWB609523S, CWB603432S, CWB605718S, CWB601752S, CWB601945S, CWB601946S, CWB602803S, CWB605225S, CWB607387S, CWB609714S, CWB605552S, CWB601729S, CWB602371S, CWB603105S, CWB603660S, CWB603852S, CWB604726S, CWB605271S, CWB608325S, CWB609120S, CWB607821S, CWB607823S, CWB607829S, CWB607834S, CWB607881S, CWB607884S, CWB607885S, CWB607886S, CWB608671S, CWB608672S, CWB608675S, CWB608676S, CWB608677S, CWB608678S, CWB608680S, CWB608681S, CWB608683S, CWB608684S, CWB608686S, CWB608687S, CWB608690S, CWB608691S, CWB608692S, CWB608697S, CWB609222S, CWB609930S, CWB609931S, CWB607959S, CWB608041S, CWB608051S, CWB608052S, CWB608055S, CWB608064S, CWB608067S, CWB608068S, CWB608069S, CWB608073S, CWB608074S, CWB608075S, CWB608081S, CWB608084S, CWB608085S, CWB608088S, CWB608089S, CWB608095S, CWB608842S, CWB608843S, CWB608844S, CWB608845S, CWB608847S, CWB608848S, CWB608849S, CWB608851S, CWB608854S, CWB608855S, CWB608856S, CWB608857S, CWB608858S, CWB608859S, CWB608861S, CWB608862S, CWB608863S, CWB606447S, CWB606663S, CWB609802S, CWB607230S, CWB608732S, CWB608748S, CWB607378S, CWB607380S, CWB607395S, CWB607440S, CWB607442S, CWB610021S, CWB610035S, CWB607236S, CWB607237S, CWB607367S, CWB607375S, CWB607376S, CWB607381S, CWB607386S, CWB607392S, CWB607398S, CWB607428S, CWB609901S, CWB609965S, CWB606256S, CWB607181S, CWB607465S, CWB607921S, CWB607969S, CWB609090S, CWB609271S, CWB609556S, CWB609976S, CWB602597S, CWB603368S, CWB604048S, CWB6056

UPC codes

00643169837720

Source

Official record: FDA (Device enforcement) ↗

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