Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; 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: 22484 units Lot/code info: GTIN 00643169837713, Lot Serial Numbers: CWA218162H, CWA219897H, CWA221224H, CWA222730H, CWA223319H, CWA224001H, CWA230660H, CWA212204H, CWA215507H, CWA219655H, CWA228049H, CWA228101H, CWA230635H, CWA230642H, CWA213967H, CWA217145H, CWA220168H, CWA225093H, CWA229346H, CWA232234H, CWA215257H, CWA215420H, CWA221756H, CWA221922H, CWA222159H, CWA225001H, CWA225149H, CWA225777H, CWA227620H, CWA227845H, CWA228935H, CWA229962H, CWA231576H, CWA231578H, CWA213741H, CWA216957H, CWA223516H, CWA225894H, CWA231485H, CWA211463H, CWA211464H, CWA211465H, CWA211466H, CWA211467H, CWA211468H, CWA211470H, CWA214199H, CWA214200H, CWA214201H, CWA214203H, CWA214205H, CWA214208H, CWA214210H, CWA214211H, CWA214212H, CWA214213H, CWA217480H, CWA217481H, CWA217482H, CWA217483H, CWA217484H, CWA217485H, CWA220397H, CWA220400H, CWA220407H, CWA220408H, CWA222904H, CWA224042H, CWA226903H, CWA226919H, CWA230608H, CWA230609H, CWA230611H, CWA230612H, CWA217020H, CWA220851H, CWA224216H, CWA226111H, CWA230832H, CWA231351H, CWA220280H, CWA222986H, CWA223614H, CWA229484H, CWA218262H, CWA224443H, CWA212537H, CWA213744H, CWA214146H, CWA214362H, CWA215549H, CWA215657H, CWA216424H, CWA216460H, CWA216476H, CWA217621H, CWA217808H, CWA217987H, CWA218225H, CWA218288H, CWA219444H, CWA219446H, CWA219708H, CWA221001H, CWA222259H, CWA222260H, CWA222261H, CWA222264H, CWA222277H, CWA222283H, CWA222284H, CWA223476H, CWA223580H, CWA223581H, CWA223745H, CWA223967H, CWA224016H, CWA224056H, CWA224540H, CWA224722H, CWA225254H, CWA2253

UPC codes

00643169837713

Source

Official record: FDA (Device enforcement) ↗

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