Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; 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: 12291 units Lot/code info: GTIN 00643169720657, Lot Serial Numbers: RPC203306H, RPC205335H, RPC207546H, RPC210227H, RPC205865H, RPC205916H, RPC205937H, RPC206296H, RPC206416H, RPC206665H, RPC207309H, RPC207864H, RPC208393H, RPC209253H, RPC209691H, RPC209707H, RPC209745H, RPC209762H, RPC209847H, RPC209918H, RPC209843H, RPC203399H, RPC204295H, RPC202725H, RPC207338H, RPC204122H, RPC210083H, RPC207179H, RPC207493H, RPC207715H, RPC208839H, RPC210208H, RPC210209H, RPC210279H, RPC202502H, RPC206685H, RPC207835H, RPC202337H, RPC203913H, RPC206604H, RPC206605H, RPC206608H, RPC206609H, RPC207319H, RPC207608H, RPC209946H, RPC207476H, RPC208004H, RPC205236H, RPC207257H, RPC202491H, RPC202610H, RPC203628H, RPC203989H, RPC204238H, RPC204412H, RPC204523H, RPC205585H, RPC210162H, RPC202353H, RPC202434H, RPC202549H, RPC202947H, RPC203116H, RPC207575H, RPC202513H, RPC205862H, RPC207849H, RPC209388H, RPC210124H, RPC203780H, RPC204065H, RPC204066H, RPC210111H, RPC204504H, RPC203114H, RPC205516H, RPC205847H, RPC207025H, RPC207175H, RPC204556H, RPC207683H, RPC208161H, RPC208598H, RPC208896H, RPC209484H, RPC203280H, RPC203999H, RPC204866H, RPC204869H, RPC204871H, RPC204874H, RPC205657H, RPC205859H, RPC205860H, RPC206559H, RPC206713H, RPC207077H, RPC207577H, RPC208079H, RPC208366H, RPC209001H, RPC209018H, RPC209067H, RPC209386H, RPC202652H, RPC203629H, RPC203149H, RPC204932H, RPC206900H, RPC208153H, RPC203547H, RPC203646H, RPC203649H, RPC203650H, RPC203657H, RPC204651H, RPC204964H, RPC205201H, RPC205208H, RPC205243H, RPC2052

UPC codes

00643169720657

Source

Official record: FDA (Device enforcement) ↗

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