FDAFDA · Food and drugs·Recall number Z-0421-2024
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Published December 6, 2023 · Recall initiated: November 3, 2023
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
It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Inc.
- Distributor
- US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, Macao, Malaysia, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, Puerto Rico, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom
- Lot
- GTIN 00763000060374, Serial Numbers: RLB088215G, RLB088216G, RLB088218G, RLB091019G, RLB034146G, RLB087479G, RLB127232G, RLB096039G, RLB086587G, RLB086621G, RLB088233G, RLB088236G, RLB088253G, RLB123314G, RLB043944G, RLB043960G, RLB064996G, RLB132967G, RLB100312G, RLB129506G, RLB100832G, RLB133215G, RLB135262G, RLB095554G, RLB085079G, RLB085091G, RLB076831G, RLB039020G, RLB039027G, RLB039991G, RLB067804G, RLB067902G, RLB068380G, RLB046661G, RLB046706G, RLB032307G, RLB051206G, RLB059647G, RLB059927G, RLB059929G, RLB057274G, RLB057275G, RLB057281G, RLB049542G, RLB049547G, RLB049558G, RLB050122G, RLB050400G, RLB135044G, RLB135571G, RLB116211G, RLB116212G, RLB116278G, RLB132853G, RLB041540G, RLB080621G, RLB128220G, RLB044256G, RLB045549G, RLB045551G, RLB131768G, RLB067275G, RLB067283G, RLB076103G, RLB097835G, RLB123630G, RLB123632G, RLB123637G, RLB124673G, RLB073925G, RLB079721G, RLB082968G, RLB090643G, RLB047705G, RLB050161G, RLB051708G, RLB071194G, RLB074924G, RLB040742G, RLB040745G, RLB040747G, RLB042297G, RLB042305G, RLB126760G, RLB049893G, RLB056158G, RLB060723G, RLB067531G, RLB072387G, RLB077136G, RLB081270G, RLB074296G, RLB074299G, RLB074311G, RLB079205G, RLB079211G, RLB079220G, RLB081471G, RLB079130G, RLB079191G, RLB075572G, RLB075573G, RLB075791G, RLB046637G, RLB046831G, RLB046834G, RLB046839G, RLB046842G, RLB064638G, RLB064714G, RLB064723G, RLB064727G, RLB064729G, RLB072023G, RLB072026G, RLB072042G, RLB072045G, RLB073339G, RLB046700G, RLB046701G, RLB046707G, RLB046708G, RLB061262G, RLB061263G, RLB061471G, RLB062138G, RLB062262G, RLB067104G, RLB067110G, RLB067140G, RLB068189G, RLB069163G, RLB054816G, RLB054863G, RLB054781G, RLB054783G, RLB054785G, RLB059008G, RLB059009G, RLB062338G, RLB062068G, RLB062077G, RLB062079G, RLB062084G, RLB062085G, RLB062149G, RLB062150G, RLB060825G, RLB060834G, RLB054129G, RLB054137G, RLB054138G, RLB051687G, RLB050246G, RLB050253G, RLB050255G, RLB050283G, RLB050039G, RLB050053G, RLB050056G, RLB050057G, RLB050357G, RLB048507G, RLB048511G, RLB048512G, RLB048519G, RLB048521G, RLB037368G, RLB039661G, RLB039662G, RLB039666G, RLB039669G, RLB039718G, RLB039720G, RLB039721G, RLB040266G, RLB040269G, RLB036841G, RLB036845G, RLB037212G, RLB037622G, RLB038062G, RLB037854G, RLB037896G, RLB037918G, RLB037919G, RLB037925G, RLB037927G, RLB037931G, RLB038281G, RLB038284G, RLB038815G, RLB038963G, RLB038972G, RLB034079G, RLB034209G, RLB034211G, RLB038014G, RLB039063G, RLB032205G, RLB032219G, RLB032231G, RLB032232G, RLB032583G, RLB033606G, RLB033673G, RLB033906G, RLB033952G, RLB034021G, RLB033563G, RLB033675G, RLB033678G, RLB033679G, RLB033680G, RLB030619G, RLB031105G, RLB031107G, RLB031118G, RLB031127G, RLB031366G, RLB032071G, RLB032076G, RLB032082G, RLB032126G, RLB030444G, RLB030446G, RLB030456G, RLB033085G, RLB033096G, RLB030729G, RLB030733G, RLB031213G, RLB031259G, RLB031262G, RLB030189G, RLB030198G, RLB030208G, RLB030209G, RLB030211G, RLB030215G, RLB030216G, RLB030236G, RLB030240G, RLB030245G, RLB030296G, RLB030299G, RLB030326G, RLB030350G, RLB030351G, RLB030476G, RLB030486G, RLB030510G, RLB030512G, RLB030516G, RLB062176G, RLB062725G, RLB062734G, RLB056351G, RLB084344G, RLB084995G, RLB085128G, RLB087056G, RLB087073G, RLB087076G, RLB088090G, RLB088527G, RLB088528G, RLB088680G, RLB077294G, RLB080398G, RLB124826G, RLB042637G, RLB126567G, RLB056368G, RLB066461G, RLB070198G, RLB123329G, RLB123352G, RLB124202G, RLB126785G, RLB126787G, RLB126793G, RLB126794G, RLB126800G, RLB073358G, RLB091205G, RLB074046G, RLB079395G, RLB071122G, RLB071125G, RLB050619G, RLB050620G, RLB066974G, RLB067045G, RLB067731G, RLB069567G, RLB054719G, RLB054724G, RLB056208G, RLB056215G, RLB058914G, RLB058915G, RLB058916G, RLB058931G, RLB062130G, RLB062291G, RLB062293G, RLB062303G, RLB038599G, RLB038665G, RLB100059G, RLB066997G, RLB067306G, RLB067729G, RLB067732G, RLB067735G, RLB073461G, RLB073496G, RLB073506G, RLB073511G, RLB090396G, RLB090397G, RLB090542G, RLB090545G, RLB090549G, RLB090550G, RLB090552G, RLB090553G, RLB044412G, RLB070083G, RL
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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