FDAFDA · Food and drugs·Recall number Z-0240-2020
Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
Published November 6, 2019 · Recall initiated: October 3, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distributor
- Worldwide Distribution
- Lot
- Serial Numbers: JVD000209P JVD000233P JVD000242P JVD000243P JVD000244P JVD000245P JVD000246P JVD000247P JVD000248P JVD000249P JVD000250P JVD000251P JVD000252P JVD000253P JVD000254P JVD000255P JVD000256P JVD000257P JVD000258P JVD000259P JVD000260P JVD000261P JVD000262P JVD000263P JVD000264P JVD000265P JVD000266P JVD000267P JVD000269P JVD000270P JVD000271P JVD000272P JVD000273P JVD000274P JVD000275P JVD000276P JVD000277P JVD000278P JVD000279P JVD000280P JVD000281P JVD000282P JVD000283P JVD000284P JVD000285P JVD000286P JVD000287P JVD000288P JVD000289P JVD000290P JVD000291P JVD000292P JVD000293P JVD000294P JVD000295P JVD000297P JVD000298P JVD000299P JVD000300P JVD000301P JVD000302P JVD000303P JVD000304P JVD000305P JVD000306P JVD000307P JVD000308P JVD000309P JVD000310P JVD000311P JVD000312P JVD000313P JVD000314P JVD000315P JVD000316P JVD000317P JVD000318P JVD000319P JVD000320P JVD000321P JVD000322P JVD000323P JVD000324P JVD000325P JVD000326P JVD000327P JVD000328P JVD000329P JVD000330P JVD000331P JVD000332P JVD000333P JVD000334P JVD000335P JVD000336P JVD000337P JVD000338P JVD000339P JVD000340P JVD000341P JVD000342P JVD000343P JVD000344P JVD000345P JVD000346P JVD000347P JVD000348P JVD000349P JVD000350P JVD000351P JVD000352P JVD000353P JVD000354P JVD000355P JVD000356P JVD000357P JVD000359P JVD000360P JVD000361P JVD000362P JVD000363P JVD000364P JVD000365P JVD000366P JVD000367P JVD000368P JVD000369P JVD000370P JVD000371P JVD000372P JVD000373P JVD000374P JVD000375P JVD000376P JVD000377P JVD000378P JVD000379P JVD000380P JVD000381P JVD000382P JVD000383P JVD000384P JVD000385P JVD000386P JVD000387P JVD000388P JVD000389P JVD000390P JVD000391P JVD000392P JVD000393P JVD000394P JVD000395P JVD000396P JVD000397P JVD000398P JVD000399P JVD000400P JVD000401P JVD000402P JVD000403P JVD000404P JVD000405P JVD000406P JVD000407P JVD000408P JVD000409P JVD000410P JVD000411P JVD000412P JVD000413P JVD000414P JVD000415P JVD000416P JVD000417P JVD000418P JVD000419P JVD000420P JVD000421P JVD000422P JVD000423P JVD000424P JVD000425P JVD000426P JVD000427P JVD000428P JVD000429P JVD000430P JVD000431P JVD000432P JVD000433P JVD000434P JVD000435P JVD000436P JVD000437P JVD000438P JVD000439P JVD000440P JVD000441P JVD000442P JVD000443P JVD000456P JVD000457P JVD000458P JVD000459P JVD000460P JVD000461P JVD000462P JVD000463P JVD000464P JVD000465P JVD000466P JVD000467P JVD000468P JVD000469P JVD000470P JVD000471P JVD000472P JVD000473P JVD000474P JVD000475P JVD000476P JVD000477P JVD000480P JVD000483P JVD000484P JVD000485P JVD000486P JVD000487P JVD000488P JVD000489P JVD000490P JVD000491P JVD000492P JVD000493P JVD000494P JVD000495P JVD000496P JVD000497P JVD000498P JVD000499P JVD000500P JVD000501P JVD000502P JVD000503P JVD000504P JVD000505P JVD000506P JVD000507P JVD000508P JVD000509P JVD000510P JVD000511P JVD000512P JVD000513P JVD000514P JVD000515P JVD000516P JVD000517P JVD000518P JVD000519P JVD000520P JVD000521P JVD000522P JVD000523P JVD000524P JVD000525P JVD000526P JVD000527P JVD000528P JVD000529P JVD000530P JVD000531P JVD000532P JVD001000P JVD001001P JVD001002P JVD001003P JVD001004P JVD001005P JVD001006P JVD001007P JVD001008P JVD001009P JVD001010P JVD001011P JVD001012P JVD001013P JVD001014P JVD001015P JVD001016P JVD001017P JVD001018P JVD001019P JVD001020P JVD001021P JVD001022P JVD001023P JVD001024P JVD001025P JVD001026P JVD001027P JVD001028P JVD001029P JVD001030P JVD001031P JVD001032P JVD001033P JVD001034P JVD001035P JVD001036P JVD001037P JVD001038P JVD001039P JVD001040P JVD001041P JVD001042P JVD001043P JVD001044P JVD001045P JVD001046P JVD001047P JVD001048P JVD001049P JVD001050P JVD001051P JVD001052P JVD001053P JVD001054P JVD001055P JVD001056P JVD001057P
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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