Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; 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: 2142 units Lot/code info: GTIN 00763000178253, Lot Serial Numbers: RTS600109S, RTS600115S, RTS600751S, RTS600754S, RTS600962S, RTS600827S, RTS600976S, RTS600761S, RTS600116S, RTS600128S, RTS600174S, RTS600280S, RTS600285S, RTS600674S, RTS600094S, RTS600271S, RTS600277S, RTS600961S, RTS600987S, RTS601452S, RTS600164S, RTS600168S, RTS600203S, RTS600209S, RTS600222S, RTS600375S, RTS600636S, RTS600652S, RTS600734S, RTS600800S, RTS600876S, RTS600127S, RTS600189S, RTS600170S, RTS600171S, RTS600251S, RTS600459S, RTS600460S, RTS600464S, RTS600537S, RTS600608S, RTS600792S, RTS601104S, RTS601108S, RTS600087S, RTS600091S, RTS601032S, RTS600079S, RTS600080S, RTS600081S, RTS600083S, RTS600119S, RTS600161S, RTS600255S, RTS600258S, RTS600261S, RTS600316S, RTS600322S, RTS600418S, RTS600812S, RTS601439S, RTS601440S, RTS601454S, RTS600198S, RTS600744S, RTS600831S, RTS600843S, RTS600963S, RTS600984S, RTS600989S, RTS601015S, RTS601016S, RTS601434S, RTS601436S, RTS602647S, RTS600836S, RTS600092S, RTS600135S, RTS600136S, RTS600137S, RTS600172S, RTS600181S, RTS600224S, RTS600231S, RTS600246S, RTS600256S, RTS600264S, RTS600342S, RTS600377S, RTS600384S, RTS600385S, RTS600398S, RTS600399S, RTS600424S, RTS600430S, RTS600435S, RTS600442S, RTS600470S, RTS600599S, RTS600621S, RTS600622S, RTS600649S, RTS600668S, RTS600738S, RTS600770S, RTS600775S, RTS600780S, RTS600788S, RTS600832S, RTS600854S, RTS600861S, RTS600793S, RTS600893S, RTS601084S, RTS601095S, RTS602634S, RTS600073S, RTS600133S, RTS600156S, RTS600159S, RTS600169S, RTS6001

UPC codes

00763000178253, 00763000178277

Source

Official record: FDA (Device enforcement) ↗

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