Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.

Recall details

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Distributor

Worldwide Distribution - US Nationwide

Lot

GTIN/UPN: (a) 00643169735637 Serial Numbers: RNO201997H RNO202010H RNO202012H RNO202015H RNO202016H RNO202018H RNO202045H RNO202049H RNO202050H RNO202051H RNO202055H RNO202056H RNO202058H RNO202062H RNO202065H RNO202067H RNO202068H RNO202069H RNO202072H RNO202075H RNO202078H RNO202083H RNO202086H RNO202087H RNO202088H RNO202092H RNO202093H RNO202094H RNO202098H RNO202099H RNO202100H RNO202101H RNO201399H RNO201985H RNO201986H RNO201989H RNO201990H RNO201994H RNO201988H RNO201995H RNO202048H RNO202090H RNO202091H RNO202011H RNO201962H RNO201966H RNO201967H RNO201970H RNO201974H RNO201977H RNO201978H RNO201980H RNO201982H RNO202013H RNO202014H RNO202017H RNO202019H RNO202037H RNO202040H RNO202042H RNO202073H RNO202079H RNO202009H RNO201922H RNO201981H RNO202034H RNO200663H RNO201582H RNO201603H RNO200042H RNO200092H RNO200202H RNO200455H RNO200550H RNO200583H RNO201033H RNO201133H RNO201837H RNO201923H RNO201925H RNO201928H RNO201930H RNO201934H RNO201936H RNO201938H RNO201939H RNO201940H RNO201944H RNO201945H RNO201947H RNO201948H RNO201950H RNO201952H RNO201953H RNO201956H RNO201960H RNO201968H RNO201969H RNO201971H RNO201973H RNO200252H RNO200269H RNO201907H RNO201912H RNO201913H RNO201918H RNO201920H RNO201924H RNO201935H RNO201946H RNO201904H RNO200829H RNO200809H RNO200823H RNO200087H RNO201066H RNO201821H RNO201358H RNO200859H RNO201768H RNO201082H RNO200571H RNO200547H RNO201286H RNO200520H RNO201181H RNO201431H RNO200544H RNO201490H RNO200860H RNO201019H RNO200977H RNO200414H RNO200864H RNO200499H RNO201424H RNO201574H RNO201813H RNO201308H RNO201751H RNO201333H RNO201794H RNO201487H RNO200097H RNO201743H RNO200480H RNO201411H RNO201330H RNO200399H RNO200759H RNO201804H RNO201707H RNO201460H RNO200738H RNO201463H RNO201024H RNO200528H RNO200281H RNO201770H RNO200412H RNO201070H RNO201724H RNO201937H RNO201831H RNO200256H RNO201818H RNO200526H RNO201758H RNO201858H RNO201864H RNO201641H RNO200772H RNO201558H RNO201884H RNO200153H RNO200646H RNO200845H RNO200888H RNO201842H RNO201887H RNO201888H RNO201889H RNO200900H RNO201843H RNO201413H RNO200881H RNO200872H RNO200868H RNO201306H RNO200392H RNO201714H RNO200467H RNO201860H RNO201929H RNO201412H RNO201801H RNO201047H RNO201338H RNO201827H RNO200108H RNO200929H RNO200931H RNO201869H RNO201760H RNO201931H RNO200390H RNO201339H RNO200828H RNO201871H RNO201094H RNO201248H RNO201793H RNO200157H RNO201996H RNO201144H RNO201328H RNO200732H RNO200698H RNO201449H RNO200170H RNO201715H RNO200953H RNO200810H RNO200733H RNO201681H RNO201701H RNO201029H RNO200180H RNO200992H RNO200551H RNO201824H RNO201757H RNO201789H RNO201742H RNO201639H RNO200374H RNO200063H RNO201478H RNO201479H RNO201217H RNO201709H RNO200815H RNO201205H RNO200442H RNO200413H RNO200093H RNO200608H RNO201346H RNO201347H RNO200835H RNO201542H RNO201999H RNO200493H RNO202002H RNO201771H RNO201514H RNO201396H RNO201426H RNO200968H RNO200973H RNO201799H RNO201026H RNO200878H RNO201876H RNO201755H RNO201214H RNO201404H RNO201387H RNO200907H RNO201236H RNO201421H RNO201430H RNO200147H RNO201456H RNO201414H RNO201521H RNO201713H RNO201722H RNO201529H RNO201592H RNO200875H RNO200990H RNO201337H RNO200273H RNO200498H RNO200970H RNO201457H RNO200381H RNO200076H RNO200485H RNO201113H RNO201020H RNO201432H RNO201545H RNO200171H RNO200957H RNO201108H RNO200963H RNO200912H RNO201765H RNO202003H RNO200386H RNO201872H RNO200744H RNO201445H RNO200040H RNO201749H RNO200588H RNO201147H RNO201671H RNO201740H RNO201519H RNO201001H RNO201422H RNO200251H RNO200843H RNO201097H RNO200344H RNO201393H RNO201077H RNO201383H RNO200837H RNO201591H RNO201000H RNO201512H RNO201752H RNO201774H RNO200006H RNO201516H RN

Risk classification

Class II

Area (FDA)

device

Country

United States