Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; 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: 6821 units Lot/code info: GTIN 00643169720473, Lot Serial Numbers: BWM204909H, BWM204998H, BWM205011H, BWM205017H, BWM204963H, BWM204962H, BWM205000H, BWM204927H, BWM204911H, BWM204921H, BWM204926H, BWM204932H, BWM204936H, BWM204944H, BWM204954H, BWM204955H, BWM204959H, BWM204983H, BWM204984H, BWM204989H, BWM204990H, BWM205004H, BWM205006H, BWM205008H, BWM205013H, BWM205014H, BWM205015H, BWM205016H, BWM205019H, BWM205021H, BWM205023H, BWM205024H, BWM205027H, BWM205033H, BWM205036H, BWM205037H, BWM204792H, BWM204938H, BWM204961H, BWM204916H, BWM204922H, BWM204950H, BWM204957H, BWM204993H, BWM205009H, BWM204923H, BWM204924H, BWM204987H, BWM205028H, BWM204956H, BWM204953H, BWM204789H, BWM204790H, BWM204935H, BWM204905H, BWM204906H, BWM204960H, BWM204980H, BWM204991H, BWM204914H, BWM204933H, BWM204985H, BWM204997H, BWM204948H, BWM204971H, BWM204992H, BWM205007H, BWM205034H, BWM204793H, BWM204904H, BWM204910H, BWM204970H, BWM204977H, BWM204982H, BWM204928H, BWM204930H, BWM205002H, BWM205035H, BWM204967H, BWM204974H, BWM204966H, BWM204978H, BWM204946H; GTIN 00643169720480, Lot Serial Numbers: BWM606690S, BWM606723S, BWM608186S, BWM607102S, BWM606494S, BWM607083S, BWM606927S, BWM607005S, BWM607272S, BWM606644S, BWM606971S, BWM607093S, BWM606920S, BWM606879S, BWM606579S, BWM606943S, BWM607045S, BWM607027S, BWM606500S, BWM606861S, BWM606975S, BWM607158S, BWM606473S, BWM608141S, BWM606616S, BWM606706S, BWM606946S, BWM607013S, BWM606719S, BWM606720S, BWM607007S, BWM607154S, BWM607170S, BWM607176S, BWM608142S, BW

UPC codes

00643169720473, 00643169720480, 00643169980266

Source

Official record: FDA (Device enforcement) ↗

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