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FDAFDA · Food and drugs·Recall number Z-1607-2013

Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.

Published July 3, 2013 · Recall initiated: June 7, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Medtronic recently identified an issue with a subset of Consulta¿ CRT-P and Syncra¿ CRT-P devices during production. As of May 30, 2013, there have been no reported or confirmed device failures. However, because of the potential for malfunction, Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. The issue is unique to specifi

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
Distributor
Worldwide Distribution - USA including CA, FL, GA, KY, LA, LMN, MO, NE, NY, OK, PA, TN, TX, WI, and PR and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Latvia, Lebanon, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia ,United Arab Emirates, United Kingdom, Uruguay , and Yemen. UPDATED Physicians location in USA: AL, AR, FL, GA, IL, IN, KS. LA, ME, MI, MN, MO, NY, OH, PA, SC, TN, TX and VA. OUS: Luxembourg
Lot
UPDATED 7/18/2013: Serial Numbers: PVX610233S, PVX610234S, PVX610253S, PVX610258S, PVX610296S, PVX610302S, PVX610308S, PVX610311S, PVX610312S, PVX610313S, PVX610314S, PVX610315S, PVX610317S, PVX610318S, PVX610319S, PVX610320S, PVX610321S, PVX610323S, PVX610324S, PVX610325S, PVX610326S, PVX610328S, PVX610329S, PVX610331S, PVX610332S, PVX610334S, PVX610335S, PVX610337S, PVX610338S, PVX610339S, PVX610340S, PVX610341S, PVX610342S, PVX610343S, PVX610344S, PVX610346S, PVX610347S, PVX610348S, PVX610350S, PVX610352S, PVX610353S, PVX610355S, PVX610358S, PVX610360S, PVX610361S, PVX610364S, PVX610366S, PVX610367S, PVX610368S, PVX610371S, PVX610372S, PVX610373S, PVX610374S, PVX610375S, PVX610376S, PVX610377S, PVX610378S, PVX610379S, PVX610380S, PVX610381S, PVX610382S, PVX610383S, PVX610384S, PVX610385S, PVX610386S, PVX610387S, PVX610388S, PVX610389S, PVX610390S, PVX610391S, PVX610392S, PVX610393S, PVX610395S, PVX610396S, PVX610397S, PVX610398S, PVX610399S, PVX610400S, PVX610401S, PVX610403S, PVX610405S, PVX610407S, PVX610408S, PVX610409S, PVX610410S, PVX610411S, PVX610414S, PVX610415S, PVX610418S, PVX610420S, PVX610421S, PVX610425S, PVX610426S, PVX610428S, PVX610429S, PVX610435S, PVX610443S, PVX610444S, PVX610445S, PVX610446S, PVX610449S, PVX610450S, PVX610452S, PVX610455S, PVX610457S, PVX610458S, PVX610459S, PVX610461S, PVX610462S, PVX610465S, PVX610467S, PVX610468S, PVX610470S, PVX610473S, PVX610474S, PVX610475S, PVX610480S, PVX610481S, PVX610482S, PVX610485S, PVX610489S, PVX610494S, PVX610498S, PVX610501S, PVX610502S, PVX610509S, PVX610510S, PVX610514S, PVX610522S, PVX610523S, PVX610524S, PVX610525S, PVX610526S, PVX610527S, PVX610528S, PVX610529S, PVX610535S, PVX610543S, PVX610589S, PVX610607S, PVX610642S, PVX610644S, PVX610671S, PVX610698S, PVX610732S, PVX610742S, PVX610764S, PVX610797S, PVX610809S, PVX610817S, PVX610822S, PVX610824S, PVX610826S, PVX610828S, PVX610840S, PVX610843S, PVX610844S, PVX610845S, PVX610848S, PVX610852S, PVX610853S, PVX610855S, PVX610856S, PVX610857S, PVX610858S, PVX610859S, PVX610860S, PVX610861S, PVX610862S, PVX610863S, PVX610865S, PVX610866S, PVX610867S, PVX610868S, PVX610869S, PVX610870S, PVX610871S, PVX610872S, PVX610873S, PVX610874S, PVX610875S, PVX610876S, PVX610878S, PVX610879S, PVX610880S, PVX610881S, PVX610884S, PVX610889S, PVX610891S, PVX610892S, PZI614616S, PZI614617S, PZI614618S, PZI614619S, PZI614620S, PZI614621S, PZI614622S, PZI614623S, PZI614624S, PZI614625S, PZI614626S, PZI614627S, PZI614628S, PZI614629S, PZI614630S, PZI614631S, PZI614632S, PZI614633S, PZI614634S, PZI614635S, PZI614636S, PZI614637S, PZI614638S, PZI614639S, PZI614640S, PZI614641S, PZI614642S, PZI614643S, PZI614644S, PZI614645S, PZI614646S, PZI614647S, PZI614648S, PZI614656S, PZI614657S, PZI614658S, PZI614659S, PZI614660S, PZI614661S, PZI614662S, PZI614663S, PZI614664S, PZI614665S, PZI614666S, PZI614667S, PZI614668S, PZI614669S, PZI614670S, PZI614671S, PZI614672S, PZI614673S, PZI614674S, PZI614675S, PZI614676S, PZI614677S, PZI614678S, PZI614679S, PZI614680S, PZI614681S, PZI614682S, PZI614683S, PZI614684S, PZI614686S, PZI614687S, PZI614688S, PZI614689S, PZI614690S, PZI614691S, PZI614693S, PZI614694S, PZI614695S, PZI614696S, PZI614697S, PZI614698S, PZI614699S, PZI614700S, PZI614701S, PZI614702S, PZI614703S, PZI614704S, PZI614705S, PZI614706S, PZI614707S, PZI614708S, PZI614710S, PZI614711S, PZI614712S, PZI614713S, PZI614714S, PZI614715S, PZI614716S, PZI614717S, PZI614718S, PZI614720S, PZI614721S, PZI614722S, PZI614723S, PZI614724S, PZI614725S, PZI614726S, PZI614727S, PZI614728S, PZI614729S, PZI614730S, PZI614731S, PZI614732S, PZI614733S, PZI614734S, PZI614736S, PZI614737S, PZI614738S, PZI614739S, PZI614740S, PZI614741S, PZI614742S, PZI614743S, PZI614744S, PZI614745S, PZI614746S, PZI614747S, PZI614748S, PZI614749S, PZI614750S, PZI614751S, PZI614752S, PZI614753S, PZI614754S, PZI614755S, PZI614756S, PZI614757S, PZI614759S, PZI614760S, PZI614761S, PZI614762S, PZI614763S, PZI614764S, PZI614765S, PZI614767S, PZI614768S, PZI614769S, PZI
Risk classification
Class II
Area (FDA)
device
Country
United States

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