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U.S. Department of Health and Human Services

Class 2 Device Recall Patient Connector

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  Class 2 Device Recall Patient Connector see related information
Date Initiated by Firm June 04, 2020
Date Posted July 10, 2020
Recall Status1 Open3, Classified
Recall Number Z-2506-2020
Recall Event ID 85816
PMA Number P890003 
Product Classification Pulse generator, permanent, implantable - Product Code NVZ
Product Patient Connector, Model Number 24967
Code Information serial numbers: RFA001342A RFA001412A RFA001748A RFA001760A RFA001802A RFA001845A RFA001868A RFA001885A RFA002011A RFA002039A RFA002152A RFA003642A RFA003644A RFA003652A RFA003658A RFA003669A RFA003671A RFA003673A RFA003677A RFA003684A RFA003690A RFA003691A RFA003692A RFA003703A RFA003704A RFA003705A RFA004075A RFA004079A RFA004082A RFA004208A RFA004218A RFA004232A RFA004277A RFA004386A RFA004390A RFA004391A RFA004681A RFA004706A RFA005006A RFA005009A RFA005011A RFA005023A RFA005025A RFA005028A RFA005029A RFA005049A RFA005079A RFA005081A RFA005093A RFA005095A RFA005097A RFA005103A RFA005105A RFA005125A RFA005249A RFA005989A RFA006832A RFA008087A RFA008119A RFA008908A RFA009323A RFA010721A RFA010722A RFA010895A RFA011167A RFA011196A RFA011348A RFA011359A RFA011456A RFA011493A RFA011519A RFA011725A RFA011764A RFA011770A RFA011774A RFA011780A RFA011795A RFA011796A RFA011797A RFA011824A RFA011827A RFA011840A RFA011846A RFA011859A RFA011860A RFA011862A RFA011872A RFA011879A RFA011885A RFA011898A RFA011919A RFA011927A RFA011928A RFA011931A RFA011933A RFA011938A RFA011952A RFA011958A RFA011959A RFA011966A RFA011973A RFA011976A RFA011978A RFA012031A RFA012034A RFA012048A RFA012124A RFA012126A RFA012129A RFA012133A RFA012149A RFA012155A RFA012158A RFA012159A RFA012160A RFA012164A RFA012167A RFA012174A RFA012176A RFA012188A RFA012198A RFA012199A RFA012200A RFA012201A RFA012202A RFA012205A RFA012223A RFA012227A RFA012230A RFA012233A RFA012234A RFA012235A RFA012260A RFA012273A RFA012274A RFA012276A RFA012277A RFA012279A RFA012290A RFA012301A RFA012309A RFA012328A RFA012369A RFA012411A RFA012412A RFA012423A RFA012433A RFA012441A RFA012449A RFA012450A RFA012469A RFA012476A RFA012496A RFA012506A RFA012521A RFA012527A RFA012530A RFA012531A RFA012532A RFA012535A RFA012539A RFA012542A RFA012554A RFA012556A RFA012562A RFA012571A RFA012580A RFA012586A RFA012587A RFA012590A RFA012598A RFA012603A RFA012611A RFA012624A RFA012633A RFA012636A RFA012639A RFA012643A RFA012647A RFA012654A RFA012658A RFA012661A RFA012667A RFA012676A RFA012678A RFA012679A RFA012693A RFA012696A RFA012707A RFA012708A RFA012719A RFA012721A RFA012727A RFA012754A RFA012757A RFA012759A RFA012763A RFA012768A RFA012771A RFA012781A RFA012786A RFA012791A RFA012802A RFA012805A RFA012807A RFA012812A RFA012813A RFA012831A RFA012882A RFA012976A RFA013056A RFA013060A RFA013063A RFA013066A RFA013067A RFA013069A RFA013070A RFA013074A RFA013086A RFA013090A RFA013093A RFA013099A RFA013105A RFA013121A RFA013127A RFA013129A RFA013162A RFA013163A RFA013164A RFA013165A RFA013167A RFA013168A RFA013169A RFA013170A RFA013171A RFA013172A RFA013174A RFA013175A RFA013201A RFA013203A RFA013204A RFA013207A RFA013208A RFA013209A RFA013210A RFA013211A RFA013213A RFA013227A RFA013228A RFA013233A RFA013235A RFA013237A RFA013239A RFA013251A RFA013255A RFA013264A RFA013265A RFA013267A RFA013269A RFA013271A RFA013274A RFA013275A RFA013277A RFA013278A RFA013279A RFA013301A RFA013303A RFA013314A RFA013328A RFA013330A RFA013388A RFA013412A RFA013414A RFA013435A RFA013453A RFA013458A RFA013465A RFA013468A RFA013490A RFA013494A RFA013516A RFA013537A RFA013557A RFA013562A RFA013566A RFA013576A RFA013584A RFA013612A RFA013719A RFA013721A RFA013730A RFA013732A RFA013734A RFA013735A RFA013745A RFA013746A RFA013754A RFA013780A RFA013787A RFA013794A RFA013800A RFA013830A RFA013832A RFA013833A RFA013888A RFA013895A RFA013901A RFA013904A RFA013905A RFA013946A RFA013952A RFA013962A RFA013981A RFA014454A RFA014479A RFA014508A RFA014527A RFA014693A RFA014710A RFA014762A RFA014772A RFA014778A RFA014781A RFA014785A RFA014787A RFA014809A RFA014810A RFA014813A RFA014816A RFA014829A RFA014837A RFA014848A 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459A RFA018461A RFA018470A RFA018483A RFA018486A RFA018488A RFA018524A RFA018525A RFA018526A RFA018527A RFA018600A RFA018602A RFA018604A RFA018607A RFA018614A RFA018619A RFA018623A RFA018628A RFA018631A RFA018633A RFA018654A RFA018659A RFA018663A RFA018673A RFA018805A RFA018807A RFA018897A RFA018898A RFA018899A RFA018907A RFA018908A RFA018909A RFA018913A RFA018914A RFA018932A RFA018933A RFA018934A RFA018941A RFA018945A RFA018947A RFA018950A RFA018954A RFA018963A RFA018969A RFA018970A RFA018972A RFA018975A RFA018978A RFA018979A RFA018982A RFA018983A RFA018990A RFA018992A RFA018993A RFA018995A RFA018998A RFA019005A RFA019006A RFA019007A RFA019009A RFA019012A RFA019013A RFA019015A RFA019017A RFA019020A RFA019023A RFA019028A RFA019031A RFA019032A RFA019033A RFA019034A RFA019035A RFA019042A RFA019044A RFA019045A RFA019046A RFA019047A RFA019049A RFA019084A RFA019088A RFA019189A RFA019200A RFA019219A RFA019236A RFA019247A RFA019248A RFA019262A RFA019313A RFA019361A RFA019377A RFA019387A RFA019415A RFA019417A RFA019418A RFA019446A RFA019448A RFA019453A RFA019466A RFA019501A RFA019504A RFA019651A RFA019668A RFA019727A RFA019758A RFA019957A RFA019959A RFA019960A RFA019970A RFA019971A RFA019972A RFA019973A RFA019974A RFA019975A RFA019976A RFA019977A RFA019978A RFA019982A RFA019985A RFA020006A RFA020025A RFA020027A RFA020037A RFA020043A RFA020046A RFA020051A RFA020061A RFA020062A RFA020080A RFA020104A RFA020118A RFA020120A RFA020127A RFA020139A RFA020164A RFA020176A RFA020182A RFA020188A RFA020189A RFA020194A RFA020231A RFA020234A RFA020236A RFA020248A RFA020269A RFA020277A RFA020289A RFA020290A RFA020293A RFA020300A RFA020301A RFA020308A RFA020315A RFA020325A RFA020329A RFA020342A RFA020349A RFA020356A RFA020367A RFA020369A RFA020374A RFA020383A RFA020390A RFA020396A RFA020399A RFA020401A RFA020405A RFA020439A RFA020444A RFA020448A RFA020459A RFA020460A RFA020463A RFA020469A RFA020470A RFA020472A RFA020475A RFA020481A RFA020491A RFA020507A RFA020508A RFA020513A RFA020516A RFA020518A RFA020553A RFA020555A RFA020556A RFA020557A RFA020558A RFA020735A RFA020736A RFA020737A RFA020738A RFA020739A RFA020740A RFA020742A RFA020743A RFA020775A RFA020777A RFA020787A RFA020791A RFA020792A RFA020912A RFA020913A RFA020914A RFA020915A RFA020916A RFA020917A RFA022213A RFA022393A RFA022398A RFA022400A RFA022401A RFA022416A RFA022423A RFA022426A RFA022433A RFA022435A RFA022436A RFA022439A RFA022503A RFA022508A RFA022625A RFA022650A RFA022683A RFA022687A RFA022713A RFA022727A RFA022818A RFA022820A RFA022824A RFA022825A RFA022827A RFA022828A RFA022829A RFA022831A RFA022839A RFA022841A RFA022842A RFA022846A 
Recalling Firm/
Manufacturer		 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact Technical Services
800-638-1991
Manufacturer Reason
for Recall		 There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.
FDA Determined
Cause 2		 Software design
Action The firm initiated their medical device correction on 06/04/2020 by letter. The letter explained the problem and informed the consignee of the available software update (version 3.2.01) along with download instructions.
Quantity in Commerce 1025 devices
Distribution worldwide
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = NVZ and Original Applicant = Medtronic, Inc.
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