Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; 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: 10370 units Lot/code info: GTIN 00643169720671, Lot Serial Numbers: RPE221706H, RPE221707H, RPE221708H, RPE221712H, RPE221714H, RPE221715H, RPE222453H, RPE222479H, RPE222484H, RPE222493H, RPE223082H, RPE223083H, RPE223085H, RPE223086H, RPE223087H, RPE224112H, RPE224115H, RPE224116H, RPE224117H, RPE221282H, RPE222157H, RPE222778H, RPE222899H, RPE223002H, RPE223681H, RPE222052H, RPE224096H, RPE224699H, RPE225223H, RPE225228H, RPE225260H, RPE226241H, RPE226280H, RPE226296H, RPE226578H, RPE226614H, RPE226861H, RPE227698H, RPE227755H, RPE223791H, RPE226062H, RPE221213H, RPE221541H, RPE221727H, RPE221823H, RPE222060H, RPE222451H, RPE222481H, RPE222548H, RPE222618H, RPE222760H, RPE222970H, RPE222978H, RPE223026H, RPE224464H, RPE224543H, RPE224745H, RPE225324H, RPE225723H, RPE225724H, RPE225729H, RPE225737H, RPE220952H, RPE220957H, RPE220960H, RPE221018H, RPE221039H, RPE221251H, RPE221335H, RPE221336H, RPE222358H, RPE223216H, RPE223219H, RPE224021H, RPE224024H, RPE224026H, RPE224029H, RPE224031H, RPE224032H, RPE224827H, RPE224828H, RPE224829H, RPE224830H, RPE224832H, RPE224833H, RPE224834H, RPE224835H, RPE224836H, RPE224837H, RPE224838H, RPE224840H, RPE224841H, RPE224844H, RPE225172H, RPE221479H, RPE221865H, RPE221947H, RPE222309H, RPE222434H, RPE221087H, RPE221344H, RPE221345H, RPE221346H, RPE221889H, RPE222001H, RPE222150H, RPE222161H, RPE222223H, RPE222587H, RPE222591H, RPE222600H, RPE223003H, RPE223014H, RPE223046H, RPE223190H, RPE223192H, RPE223193H, RPE223197H, RPE223199H, RPE223203H, RPE223533H, RPE2239

UPC codes

00643169720671

Source

Official record: FDA (Device enforcement) ↗

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