Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator: NxT DR ICD REF CDDRA600Q Entrant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA300Q Entrant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA300Q The primary function of ICDs and CRT-Ds are to treat life-threatening ventricular tachyarrhythmias via anti-tachycardia pacing (ATP), or cardioversion/defibrillation. Implantable Cardioverter Defibrillators (ICDs) can either be a dual chamber (also known as DR if rate responsive) device that is connected to a right atrial (RA) pacing lead and right ventricular defibrillation lead or single chamber ICD (also known as VR if rate responsive) with only a defibrillation lead in the right ventricle (RV). The ICD, more generally known as an implantable pulse generator (IPG), is typically implanted in a subcutaneous device pocket located in the pectoral region and is attached to the pacing/defibrillator leads that are implanted through the transvenous technique with the distal tips positioned in the RA (dual chamber) and RV. Cardiac Resynchronization Therapy Defibrillator (CRT-D) systems consist of a right atrial (RA) pacing lead, a right ventricular (RV) defibrillation lead, as well as a third lead placed in the coronary venous system overlying the left ventricle (LV) to improve ventricular resynchronization through biventricular pacing for treatment of heart failure. CRT-D devices, more generally known as an implantable pulse generator (IPG), are typically implanted in a subcutaneous device pocket located in the pectoral region and are attached to the pacing/defibrillator leads that are implanted through transvenous technique.

Recall details

Manufacturer

Abbott Medical

Distributor

U.S.: Nation-wide O.U.S.: Australia, Austria, Bahrain, Belgium, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Nepal, Netherlands, New Zealand, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom. Latin America - Pending

Lot

Gallant: Model Number: VR ICD REF CDVRA500Q UDI-DI Code: 05415067031990 Serial Numbers: 111033498 810000696 810002524 111031208 111025117 111030959 111006327 111028481 111014296 111033775 810021414 810001946 810001996 810002011 810001942 810007459 111036536 810019608 810019393 810019581 111042257 810026722 810028531 810028585 810027003 111011936 810021423 111025530 111015227 111036960 810026790 111036957 111036933 111036964 111007506 810021413 810021445 810021449 111033604 111000553 111000558 111000567 111000472 111000706 111000667 111006793 111000664 111000678 111018664 111018644 111018802 111012460 111006783 111006791 111006789 111000786 111000582 111000550 111000721 111001035 111001025 111014950 111021456 111021461 111021703 111021722 111021450 111036417 111012272 111011597 810001013 810001011 810006759 810001046 810001021 810019014 111024417 810002439 111024415 810006774 111024454 810022318 111036914 810013066 810015963 111002002 810021662 810013192 810011364 111003380 810011481 111020960 111011436 111020992 810015820 810015794 111009835 111004271 111003046 111024175 111022969 111009840 810019313 810018954 111021002 111009844 810008620 111010818 810018999 111021710 810016110 810019437 810008498 111024550 810008497 810019426 810011359 810019424 810011511 810011353 810011328 111011181 111011372 111021007 111021712 111024183 810013436 810019054 810019546 810022117 810027515 810013071 810007469 111020996 111009733 111003861 111009782 810011335 810016103 111021851 810004570 111008584 111009245 111003267 810008499 111021988 111012318 111003040 111010800 111003332 111022768 810016526 810027041 111009747 810013248 111011899 111010457 810021351 810021705 810015780 111018656 111010771 111021437 810005318 111010761 111022974 111021994 810007454 810008483 810011285 810011458 810005317 111008582 111003173 111008588 111003555 111018654 810027111 810019552 810016459 111009820 810008557 810026959 111002712 111021707 111006776 111006779 111010814 111017230 810021576 810016112 111003506 810027040 810027014 810003350 111009781 111018131 810021674 111011908 810008527 810019917 111008583 810008575 111004282 810016339 810027099 810015815 810016102 111002437 111011229 111018270 810021707 810013068 810013216 810015840 810018976 810021355 810011459 111003500 111019459 810003430 111009834 111010787 111000447 111004193 111009841 111013996 111011233 111011254 111021837 111019423 810011451 111018786 810016113 810016649 810013446 810013250 810013442 810027039 810026943 810026944 810027020 810027165 111009759 111006801 111021440 111010437 111019431 810011457 810016665 810016449 810019012 810021618 810008573 810021560 810011535 111009788 810013454 810008650 810015824 111006778 810005319 111024379 810013349 810004013 111009809 810008519 111024368 810003553 111024378 111006784 810016140 810008486 111006797 810013266 111018109 111018795 111022789 111011910 810021606 810007463 810007421 810003677 111011216 810027514 111018640 810019556 810008612 111018784 111024402 810003437 810011343 810008526 111004721 111021995 810027548 810018995 810016138 810019427 810005706 111022585 810011387 111018291 111011963 111009708 111010450 111017239 111022090 111024180 111011906 111021723 111021436 810022090 810015784 111009794 111021433 810003343 810013241 111010980 810027103 111011915 111002410 810027161 111001995 111009741 111006541 111002011 810016121 111004259 111003960 810021559 111024204 810013232 111016740 810027168 810015796 111001027 111012290 111002434 111010962 111001969 810015822 111016745 111024202 111012258 111010952 111024184 111013804 111022788 111010465 810019529 810011303 111013808 810011549 810011538 111021812 810005366 810007473 111023732 111014948 111013807 111001583 111023720 111022587 111011938 810026979 111012462 111012307 111003869 111024186 810016277 111004242 810005286 111022781 111021845 810004846 810015783 111019446 810022064 111010799 111011214 810022363 111009828 810008597 111021790 111003559 810016560 111011185 810013225 111013993 810013206 11

Risk classification

Class II

Area (FDA)

device

Country

United States