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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Power Supply 26907

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  Class 2 Device Recall Medtronic Power Supply 26907 see related information
Date Initiated by Firm January 17, 2019
Create Date February 16, 2019
Recall Status1 Terminated 3 on March 30, 2021
Recall Number Z-0845-2019
Recall Event ID 81950
PMA Number P890003 
Product Classification Pacemaker/icd/crt non-implanted components - Product Code OSR
Product Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Code Information UPN: 00643169121973 Lot/Serial Numbers: JVD000376P JVD000415P JVD000242P JVD000262P JVD000264P JVD000272P JVD000278P JVD000283P JVD000289P JVD000291P JVD000293P JVD000295P JVD000300P JVD000311P JVD000316P JVD000320P JVD000330P JVD000332P JVD000333P JVD000334P JVD000337P JVD000338P JVD000344P JVD000346P JVD000348P JVD000350P JVD000351P JVD000352P JVD000354P JVD000356P JVD000357P JVD000359P JVD000360P JVD000361P JVD000362P JVD000363P JVD000364P JVD000367P JVD000369P JVD000373P JVD000377P JVD000379P JVD000381P JVD000382P JVD000383P JVD000384P JVD000388P JVD000390P JVD000392P JVD000394P JVD000407P JVD000408P JVD000409P JVD000410P JVD000411P JVD000412P JVD000413P JVD000417P JVD000419P JVD000420P JVD000421P  UPN: 0643169166974 Lot/Serial Numbers: JVD000331P JVD000426P JVD000430P  UPN: 00643169166981 Lot/Serial Numbers: JVD000273P JVD000275P JVD000299P JVD000307P JVD000339P  UPN: 00643169166998 Lot/Serial Numbers: JVD000245P JVD000265P JVD000297P JVD000301P JVD000313P JVD000387P JVD000391P JVD001090P JVD001137P  UPN: 00643169167001 Lot/Serial Numbers: JVD000353P JVD000395P  UPN: 00643169167018 Lot/Serial Numbers: JVD000386P JVD000389P JVD000425P JVD000432P JVD000269P JVD000290P JVD000326P  UPN: 00643169167025 Lot/Serial Numbers:  JVD000439P JVD000308P JVD000385P JVD001089P JVD000370P  UPN: 00643169167049 Lot/Serial Numbers: JVD000322P JVD000378P JVD000418P JVD000434P  UPN: 00643169167063 Lot/Serial Numbers: JVD000298P JVD000305P JVD000318P JVD000342P JVD000355P  UPN: 00643169167070 Lot/Serial Numbers: JVD000374P JVD000292P JVD000324P JVD000343P JVD000371P JVD000247P JVD000257P JVD000261P JVD000287P JVD000372P JVD000399P JVD000405P JVD000414P  UPN: 00643169167087 Lot/Serial Numbers: JVD000253P JVD000263P JVD000284P JVD000304P JVD000317P JVD000319P JVD000393P JVD000398P JVD000402P JVD001031P JVD001091P  UPN: 00643169167094 Lot/Serial Numbers: JVD000282P JVD000271P JVD000397P JVD000404P  UPN: 00643169167100 Lot/Serial Numbers: JVD000267P JVD001004P JVD000294P JVD000314P  UPN: 00643169225732 Lot/Serial Numbers: JVD001067P JVD001068P JVD001098P JVD001112P JVD001146P JVD001147P JVD001008P JVD001016P JVD001063P JVD001064P JVD001065P JVD000525P JVD001002P JVD000474P JVD000489P JVD000501P JVD000523P JVD000463P JVD000473P JVD000484P JVD000459P  UPN: 00643169225749 Lot/Serial Numbers: JVD000251P JVD000266P JVD000285P  UPN: 00643169225756 Lot/Serial Numbers: JVD000347P JVD000288P  UPN: 00643169225763 Lot/Serial Numbers:  JVD000259P JVD000260P  UPN: 00643169225770 Lot/Serial Numbers: JVD000244P JVD000254P JVD000256P JVD000258P JVD000276P JVD000309P JVD000310P  UPN: 00643169369030 Lot/Serial Numbers: JVD001032P JVD001271P JVD000279P JVD000437P JVD001027P JVD002984P JVD002985P JVD002986P JVD002988P JVD002989P JVD002991P JVD002992P JVD002996P JVD002997P JVD002999P JVD003001P JVD003002P JVD003004P JVD003006P JVD001389P JVD001465P JVD000255P JVD001024P JVD001186P JVD001212P JVD001226P JVD001235P JVD001242P JVD001292P JVD001406P JVD001454P JVD001481P JVD001502P JVD001345P JVD001185P JVD001267P JVD001347P JVD000401P JVD001026P JVD001110P JVD001152P JVD001203P JVD001247P JVD001311P JVD001507P JVD000321P JVD000336P JVD000424P JVD000428P JVD000461P JVD000487P JVD000493P JVD000528P JVD001000P JVD001102P JVD001104P JVD001106P JVD001115P JVD001138P JVD001157P JVD001171P JVD001178P JVD001179P JVD001187P JVD001191P JVD001202P JVD001204P JVD001208P JVD001214P JVD001221P JVD001246P JVD001260P JVD001298P JVD001299P JVD001306P JVD001308P JVD001314P JVD001349P JVD001387P JVD001419P JVD001431P JVD001434P JVD001447P JVD001617P JVD001018P JVD001448P JVD001289P JVD001415P JVD001023P JVD001253P JVD001466P JVD001467P JVD001283P JVD001512P JVD001057P JVD001430P JVD001571P JVD001254P JVD001309P JVD001468P JVD001470P JVD001182P JVD001375P JVD001161P JVD000496P JVD001162P JVD001380P JVD001085P JVD001441P JVD000423P JVD001426P JVD000328P JVD001164P JVD001172P JVD001087P JVD001453P JVD001218P JVD000427P JVD000524P JVD001007P JVD001061P JVD001386P JVD001417P JVD001491P JVD001055P JVD001094P JVD001378P JVD000274P JVD000502P JVD000503P JVD001052P JVD001070P JVD001176P JVD001461P JVD001483P JVD000368P JVD001078P JVD001265P JVD001450P JVD001009P JVD001416P JVD001047P JVD000329P JVD001370P JVD000277P JVD000323P JVD001194P JVD001363P JVD001036P JVD000480P JVD001167P JVD001328P JVD001359P JVD001001P JVD000464P JVD001056P JVD001425P JVD001046P JVD001005P JVD000491P JVD001132P JVD001219P JVD001291P JVD001071P JVD001072P JVD001352P JVD001492P JVD000280P JVD000472P JVD000531P JVD001021P JVD001042P JVD001045P JVD001082P JVD001183P JVD001301P JVD001364P JVD000519P JVD000466P JVD001356P JVD001059P JVD001159P JVD000494P JVD001030P JVD001109P JVD001116P JVD001455P JVD001077P JVD001486P JVD000286P JVD000312P JVD001438P JVD001510P JVD001160P JVD001262P JVD001270P JVD001284P JVD000513P JVD001107P JVD001108P JVD001540P JVD001213P JVD001230P JVD001158P JVD001233P JVD001193P JVD001224P JVD001288P JVD001290P JVD001407P JVD000438P JVD000504P JVD001256P JVD000488P JVD001125P JVD001232P JVD001245P JVD001278P JVD001279P JVD001281P JVD001432P JVD001261P JVD001268P JVD001493P JVD001096P JVD001080P JVD000508P JVD001049P JVD001197P JVD001251P JVD001274P JVD001484P JVD001442P JVD001495P JVD000462P JVD001105P JVD001128P JVD001225P JVD001294P JVD001422P JVD000515P JVD000516P JVD001180P JVD001383P JVD001457P JVD000526P JVD001041P JVD001083P JVD001111P JVD001354P JVD001396P JVD001471P JVD001220P JVD001286P JVD001139P JVD001413P JVD001472P JVD000302P JVD000396P JVD000400P JVD000475P JVD000483P JVD000486P JVD000490P JVD000498P JVD000514P JVD000517P JVD000532P JVD001003P JVD001019P JVD001022P JVD001033P JVD001034P JVD001043P JVD001048P JVD001051P JVD001053P JVD001079P JVD001084P JVD001092P JVD001095P JVD001097P JVD001099P JVD001103P JVD001131P JVD001133P JVD001134P JVD001135P JVD001150P JVD001151P JVD001154P JVD001163P JVD001168P JVD001169P JVD001170P JVD001181P JVD001188P JVD001189P JVD001190P JVD001192P JVD001196P JVD001198P JVD001199P JVD001200P JVD001201P JVD001210P JVD001217P JVD001227P JVD001229P JVD001244P JVD001248P JVD001249P JVD001257P JVD001263P JVD001264P JVD001272P JVD001273P JVD001282P JVD001293P JVD001303P JVD001307P JVD001312P JVD001323P JVD001343P JVD001351P JVD001353P JVD001358P JVD001362P JVD001365P JVD001367P JVD001371P JVD001372P JVD001373P JVD001379P JVD001381P JVD001382P JVD001384P JVD001385P JVD001391P JVD001392P JVD001394P JVD001395P JVD001405P JVD001420P JVD001421P JVD001427P JVD001433P JVD001436P JVD001451P JVD001480P JVD001482P JVD001494P JVD001504P JVD001020P JVD001240P JVD001313P JVD001410P JVD001165P JVD001148P JVD000499P JVD000500P JVD000505P JVD001445P JVD000380P JVD000520P JVD001006P JVD001100P JVD001175P JVD001252P JVD001460P JVD001477P JVD001404P JVD001485P JVD000465P JVD001231P JVD000375P JVD000436P JVD000485P JVD001144P JVD001402P JVD000303P JVD000315P JVD000325P JVD000327P JVD000335P JVD000345P JVD000349P JVD000365P JVD000366P JVD000406P JVD000416P JVD000422P JVD000433P JVD000435P JVD000442P JVD000443P JVD000458P JVD000468P JVD000469P JVD000476P JVD000477P JVD000512P JVD001011P JVD001017P JVD001040P JVD001044P JVD001060P JVD001073P JVD001074P JVD001081P JVD001088P JVD001113P JVD001117P JVD001119P JVD001120P JVD001121P JVD001122P JVD001123P JVD001140P JVD001141P JVD001153P JVD001184P JVD001195P JVD001206P JVD001211P JVD001215P JVD001216P JVD001228P JVD001243P JVD001259P JVD001280P JVD001285P JVD001287P JVD001302P JVD001319P JVD001322P JVD001324P JVD001350P JVD001357P JVD001361P JVD001374P JVD001376P JVD001388P JVD001390P JVD001393P JVD001411P JVD001418P JVD001423P JVD001429P JVD001440P JVD001443P JVD001449P JVD001462P JVD000306P JVD000460P JVD000471P JVD000495P JVD000506P JVD000507P JVD001066P JVD001086P JVD001222P JVD001223P JVD001236P JVD001239P JVD001275P JVD001276P JVD001277P JVD001295P JVD001296P JVD001310P JVD001377P JVD001444P JVD001446P JVD001496P JVD000243P JVD000246P JVD000248P JVD000249P JVD000250P JVD000252P JVD000270P JVD000281P JVD000340P JVD000341P JVD000403P JVD000429P JVD000431P JVD000440P JVD000441P JVD000456P JVD000457P JVD000470P JVD000492P JVD000510P JVD000527P JVD000530P JVD001010P JVD001012P JVD001013P JVD001015P JVD001035P JVD001037P JVD001039P JVD001050P JVD001054P JVD001058P JVD001075P JVD001076P JVD001093P JVD001101P JVD001114P JVD001118P JVD001124P JVD001126P JVD001127P JVD001129P JVD001142P JVD001143P JVD001149P JVD001155P JVD001156P JVD001166P JVD001173P JVD001174P JVD001177P JVD001205P JVD001207P JVD001209P JVD001234P JVD001237P JVD001238P JVD001241P JVD001250P JVD001255P JVD001258P JVD001266P JVD001269P JVD001297P JVD001300P JVD001304P JVD001305P JVD001355P JVD001360P JVD001366P JVD001369P JVD001399P JVD001412P JVD001414P JVD001424P JVD001428P JVD001435P JVD001439P JVD001452P JVD001456P JVD001458P JVD001459P JVD001463P JVD001469P JVD001497P JVD001498P JVD001501P JVD001515P 
Recalling Firm/
Manufacturer		 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
Manufacturer Reason
for Recall		 There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some cases disconnecting from the programmer.
FDA Determined
Cause 2		 Device Design
Action In the US, beginning 17-Jan-2019, Medtronic Field Representatives (Field Reps) will locate all Encore programmers both in their trunk stock and in consignment locations. Since the Encore Power Supplies are interchangeable among all Encores, all Encore programmer distributed units are being located, and the associated Power Supplies will be checked to identify any affected units. If the Field Rep identifies an affected Power Supply physically at a customer account, the Medtronic Field Rep will hand deliver a courtesy FCA Notification Letter with instructions to the Risk Manager or HealthCare Professional at the account.
Quantity in Commerce 731 units
Distribution US and Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = OSR and Original Applicant = Medtronic, Inc.
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