Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; 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: 6525 units Lot/code info: GTIN 00643169837775, Lot Serial Numbers: CWF606066S, CWF601772S, CWF604835S, CWF604967S, CWF605332S, CWF601390S, CWF603522S, CWF602774S, CWF605900S, CWF600919S, CWF600938S, CWF601256S, CWF601551S, CWF601593S, CWF601753S, CWF601934S, CWF601936S, CWF602109S, CWF602581S, CWF602772S, CWF603413S, CWF603447S, CWF605891S, CWF602270S, CWF602324S, CWF602338S, CWF602553S, CWF602554S, CWF602674S, CWF602675S, CWF602677S, CWF602751S, CWF602752S, CWF602816S, CWF602823S, CWF602996S, CWF602998S, CWF603000S, CWF603013S, CWF603171S, CWF603174S, CWF603319S, CWF603361S, CWF603362S, CWF603363S, CWF603393S, CWF603406S, CWF603408S, CWF603718S, CWF603720S, CWF603721S, CWF603829S, CWF603830S, CWF603831S, CWF603832S, CWF603925S, CWF603931S, CWF603944S, CWF603996S, CWF603999S, CWF604002S, CWF604003S, CWF604004S, CWF604007S, CWF604008S, CWF604010S, CWF604598S, CWF604686S, CWF604814S, CWF604816S, CWF606151S, CWF606180S, CWF601291S, CWF601561S, CWF601672S, CWF601977S, CWF602155S, CWF606035S, CWF601562S, CWF601736S, CWF601666S, CWF602110S, CWF601293S, CWF601557S, CWF601667S, CWF601782S, CWF602154S, CWF601290S, CWF601563S, CWF605395S, CWF601668S, CWF601669S, CWF601675S, CWF606033S, CWF602902S, CWF601471S, CWF602974S, CWF603047S, CWF602754S, CWF603306S, CWF603470S, CWF603528S, CWF603652S, CWF603703S, CWF604018S, CWF604422S, CWF602486S, CWF600962S, CWF601720S, CWF603131S, CWF600875S, CWF601119S, CWF601286S, CWF601386S, CWF602245S, CWF602849S, CWF603471S, CWF603642S, CWF604496S, CWF602510S, CWF604175S, CWF6042

UPC codes

00643169837775

Source

Official record: FDA (Device enforcement) ↗

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