Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; 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: 4767 units Lot/code info: GTIN 00643169837638, Lot Serial Numbers: RPP602125S, RPP602593S, RPP603699S, RPP602902S, RPP602417S, RPP601873S, RPP602956S, RPP601533S, RPP603620S, RPP600808S, RPP603725S, RPP602431S, RPP602451S, RPP602452S, RPP602460S, RPP602737S, RPP602741S, RPP602778S, RPP602780S, RPP603298S, RPP603299S, RPP603300S, RPP603303S, RPP603679S, RPP603685S, RPP603686S, RPP603690S, RPP603812S, RPP603814S, RPP603815S, RPP603819S, RPP603821S, RPP603822S, RPP603825S, RPP603832S, RPP603833S, RPP603840S, RPP603843S, RPP603844S, RPP603847S, RPP603848S, RPP603849S, RPP603852S, RPP603855S, RPP603859S, RPP603860S, RPP603861S, RPP603862S, RPP603863S, RPP603868S, RPP603870S, RPP603871S, RPP602254S, RPP603326S, RPP601331S, RPP601392S, RPP602961S, RPP601050S, RPP602800S, RPP603221S, RPP602233S, RPP603560S, RPP603768S, RPP603806S, RPP600598S, RPP602145S, RPP602648S, RPP602799S, RPP603486S, RPP603323S, RPP600640S, RPP602076S, RPP602927S, RPP602720S, RPP602731S, RPP602825S, RPP603224S, RPP603469S, RPP603540S, RPP603121S, RPP601248S, RPP603177S, RPP603172S, RPP603771S, RPP602869S, RPP601435S, RPP601415S, RPP600928S, RPP601427S, RPP602144S, RPP603032S, RPP603520S, RPP602501S, RPP603038S, RPP601593S, RPP602078S, RPP602304S, RPP602511S, RPP602666S, RPP603530S, RPP603735S, RPP603818S, RPP601857S, RPP601924S, RPP602614S, RPP602678S, RPP602682S, RPP601024S, RPP603775S, RPP600608S, RPP602566S, RPP603774S, RPP602077S, RPP603233S, RPP603275S, RPP603548S, RPP603666S, RPP601938S, RPP601669S, RPP601446S, RPP602806S, RPP6020

UPC codes

00643169837638

Source

Official record: FDA (Device enforcement) ↗

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