Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; 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: 1076 units Lot/code info: GTIN 00643169720350, Lot Serial Numbers: BLS604430S, BLS604248S, BLS604229S, BLS604258S, BLS604234S, BLS604223S, BLS604309S, BLS604224S, BLS604227S, BLS604222S, BLS604308S, BLS604256S, BLS604257S, BLS604310S, BLS604313S, BLS604245S, BLS604253S, BLS604252S, BLS604239S, BLS604226S, BLS604371S, BLS604380S, BLS604417S, BLS604419S, BLS604432S, BLS604560S, BLS604562S, BLS604366S, BLS604368S, BLS604375S, BLS604376S, BLS604169S, BLS604170S, BLS604360S, BLS604365S, BLS604369S, BLS604372S, BLS604379S, BLS604525S, BLS604554S, BLS604572S, BLS604363S, BLS604171S, BLS604361S, BLS604377S, BLS604378S, BLS604418S, BLS604428S, BLS604434S, BLS604556S, BLS604561S, BLS604567S, BLS604571S, BLS604563S, BLS604362S, BLS604364S, BLS604370S, BLS604373S, BLS604422S, BLS604523S, BLS604524S, BLS604543S, BLS604548S, BLS604564S, BLS604570S, BLS604279S, BLS604280S, BLS604281S, BLS604316S, BLS604320S, BLS604321S, BLS604322S, BLS604323S, BLS604324S, BLS604326S, BLS604328S, BLS604317S, BLS604318S, BLS604319S, BLS604416S, BLS604421S, BLS604243S, BLS604305S, BLS604399S, BLS604503S, BLS604549S, BLS604367S, BLS604345S, BLS604501S, BLS604410S, BLS604502S, BLS604528S, BLS604325S, BLS604384S, BLS604391S, BLS604392S, BLS604400S, BLS604487S, BLS604496S, BLS604385S, BLS604386S, BLS604520S, BLS604521S, BLS604390S, BLS604397S, BLS604406S, BLS604526S, BLS604527S, BLS604382S, BLS604408S, BLS604249S, BLS604250S, BLS604387S, BLS604388S, BLS604389S, BLS604393S, BLS604413S, BLS604414S, BLS604457S, BLS604458S, BLS604459S, BLS6044

UPC codes

00643169720350, 00643169980105, 00763000612276

Source

Official record: FDA (Device enforcement) ↗

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