European Withdrawn Literature (English)

This webpage provides access to prior revisions of Directions for Use and product manuals for products sold in the European Union where this literature was exclusively provided electronically after 01 March, 2013.

  • NOTE: Prior Revision documents are watermarked and provided for REFERENCE ONLY.
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  • INGEVITY™ MRI

    Instructions for Use

    Cardiac Lead

    Apr 04, 2024

    Product Code 7731; 7732; 7735; 7736

    Part Number 358661-112

    Applicable To Pace/Sense Lead; IS-1 Bipolar Connector; Tined Fixation

    Safety Related Revision No

  • LATITUDE™

    Clinician Manuals

    LATITUDE NXT Patient Management System

    Jul 01, 2022

    Product Code 6280; 6288; 6290; 6446; 6447; 6448; 6468; 6496; 6498

    Part Number 358827-075

    Safety Related Revision No

  • LATITUDE™ NXT

    Clinician Manuals

    LATITUDE NXT Patient Management System

    Jun 24, 2025

    Product Code 6448

    Part Number 358827-086P

    Safety Related Revision No

  • FINELINE™ II Sterox;VISIONIST™ X4;INGEVITY™+;FORMIO™ MRI;FINELINE™ II Sterox EZ;ADVANTIO™ MRI;ACCOLADE™ MRI;INGENIO™ MRI;INGEVITY™ MRI;PROPONENT™ MRI;ACUITY™ X4 Spiral L;VITALIO™ MRI;FINELINE™ II;ACUITY™ X4 Straight;ACUITY™ X4 Spiral S;VALITUDE™ X4;ESSENTIO™ MRI

    MRI Information

    IMAGEREADY™ MR Conditional Pacing System

    Mar 23, 2023

    Product Code J065; J066; J067; J175; J176; J177; J275; J276; J277; J279; L110; L111; L131; L210; L211; L231; L310; L311; L331; U128; U228; 4456; 4457; 4458; 4459; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6220; 6221; 6402; 7145; 7148; 7731; 7732; 7735; 7736; 7740; 7741; 7742; 7840; 7841; 7842

    Part Number 359259-054

    Applicable To IMAGEREADY™

    Applicable To N/A

    Safety Related Revision No

  • LATITUDE™ Communicator

    Patient Information

    LATITUDE™ Communicator

    Jun 03, 2025

    Product Code 6288; 6290

    Part Number 359422-003

    Safety Related Revision No

  • LATITUDE™

    Integration Guides

    LATITUDE NXT Patient Management System

    Jun 03, 2025

    Product Code 6624

    Part Number 359483-001

    Applicable To LATITUDE™ NXT - LATITUDE INTEGRATION IDCO AND HL7 SPECIFICATIONS

    Safety Related Revision No

  • CHARISMA™ EL ICD;CHARISMA™ CRT-D;FINELINE™ II Sterox;RESONATE™ CRT-D;RESONATE™ HF ICD;INOGEN™ MINI ICD;AUTOGEN™ MINI ICD;PERCIVA™ ICD;MOMENTUM™ CRT-D;DYNAGEN™ CRT-D;MOMENTUM™ EL ICD;AUTOGEN™ EL ICD;RESONATE™ X4 CRT-D;RESONATE™ HF CRT-D;CHARISMA™ X4 CRT-D;INGEVITY™ MRI;MOMENTUM™ X4 CRT-D;ORIGEN™ MINI ICD;ORIGEN™ EL ICD;ENDOTAK RELIANCE™;VIGILANT™ EL ICD;AUTOGEN™ X4 CRT-D;VIGILANT™ CRT-D;DYNAGEN™ EL ICD;EASYTRAK™ 2 IS-1;PERCIVA™ HF ICD;RELIANCE™ 4-FRONT;INOGEN™ CRT-D;FINELINE™ II Sterox EZ;INOGEN™ EL ICD;VIGILANT™ X4 CRT-D;INOGEN™ X4 CRT-D;EASYTRAK™ 2;DYNAGEN™ MINI ICD;RESONATE™ EL ICD;ACUITY™ X4 Spiral L;ORIGEN™ X4 CRT-D;AUTOGEN™ CRT-D;ACUITY™ X4 Straight;FINELINE™ II;ORIGEN™ CRT-D;ACUITY™ Spiral;ACUITY™ X4 Spiral S;DYNAGEN™ X4 CRT-D

    MRI Information

    IMAGEREADY™ MR Conditional Defibrillation System

    Dec 05, 2022

    Product Code D000; D001; D002; D003; D010; D011; D012; D013; D020; D021; D022; D023; D044; D045; D046; D047; D050; D051; D052; D053; D120; D121; D140; D141; D142; D143; D150; D151; D152; D153; D174; D175; D176; D177; D220; D221; D232; D233; D320; D321; D332; D333; D400; D401; D412; D413; D420; D421; D432; D433; D500; D501; D512; D513; D520; D521; D532; D533; G050; G051; G056; G058; G124; G125; G128; G138; G140; G141; G146; G148; G150; G151; G156; G158; G172; G173; G177; G179; G224; G225; G228; G237; G247; G248; G324; G325; G328; G337; G347; G348; G424; G425; G428; G437; G447; G448; G524; G525; G528; G537; G547; G548; 0127; 0128; 0129; 0137; 0138; 0139; 0143; 0147; 0148; 0149; 0153; 0157; 0158; 0159; 0170; 0171; 0172; 0173; 0174; 0175; 0176; 0177; 0180; 0181; 0182; 0183; 0184; 0185; 0186; 0187; 0262; 0263; 0265; 0266; 0272; 0273; 0275; 0276; 0282; 0283; 0285; 0286; 0292; 0293; 0295; 0296; 0636; 0650; 0651; 0652; 0653; 0654; 0655; 0657; 0658; 0662; 0663; 0665; 0672; 0673; 0675; 0676; 0682; 0683; 0685; 0686; 0692; 0693; 0695; 0696; 4469; 4470; 4471; 4472; 4473; 4474; 4479; 4480; 4542; 4543; 4544; 4591; 4592; 4593; 4603; 4671; 4672; 4674; 4675; 4677; 4678; 6100; 6220; 6221; 6402; 6403; 6773; 6996; 7145; 7148; 7735; 7736; 7740; 7741; 7742

    Part Number 51114107-001

    Applicable To IMAGEREADY™

    Safety Related Revision No

  • INGEVITY™+

    Instructions for Use

    Pace/Sense Lead IS-1 Bipolar Connector Extendable/Retractable Fixation

    Oct 27, 2023

    Product Code 7840; 7841; 7842

    Part Number 92383240-001

    Applicable To N/A

    Applicable To N/A

  • LATITUDE™ Communicator

    Patient Information

    PATIENT MANUAL

    Aug 16, 2024

    Product Code 6288; 00802526617508; 6288; 00802526617423; 6288; 00802526577376; 6288; 00802526577383; 6288; 00802526616518; 6288; 00802526577413; 6288; 00802526617409; 6290; 00802526617805; 6290; 00802526617843; 6290; 00802526585678; 6290; 00802526585685; 6290; 00802526617812; 6290; 00802526585715; 6290; 00802526617829; 6290; 00802526617836; 6290; 00802526585739; 6290; 00802526606236; 6290; 00802526618918; 6290; 00802526606212

    Part Number 92435999-001

    Safety Related Revision No

  • LATITUDE™ NXT

    Clinician Manuals

    LATITUDE NXT Patient Management System

    Oct 27, 2023

    Product Code 6468; 6496; 6446; 00802526613821; 6448; 00802526613814; 6288; 00802526617508; 6288; 00802526617423; 6288; 00802526577376; 6288; 00802526577383; 6288; 00802526616518; 6288; 00802526577413; 6288; 00802526617409; 6290; 00802526617805; 6290; 00802526617843; 6290; 00802526585678; 6290; 00802526585685; 6290; 00802526617812; 6290; 00802526585715; 6290; 00802526617829; 6290; 00802526617836; 6290; 00802526585739; 6290; 00802526606236; 6290; 00802526618918; 6290; 00802526606212

    Part Number 92436023-001

    Safety Related Revision No

  • LATITUDE™ Communicator

    Quick Start Guide;Patient Information

    QUICK START GUIDE

    Aug 16, 2024

    Product Code 6288; 00802526577413; 6290; 00802526617812; 6290; 00802526585715; 6290; 00802526606236; 6290; 00802526618918; 6290; 00802526606212; 6290; 00802526585739

    Part Number 92446237-001

    Safety Related Revision Blank

  • Orbera® Gastric Balloons

    Instructions for Use

    Intragastric Balloon System; Система на вътрешностомашен балон; 胃内球囊系统; sustav intragastričnog balona; Intragastrický balónkový systém; Intragastrisk ballonsystem; Maagballonsysteem; Maosisene balloonisüsteem; Mahalaukunsisäinen pallojärjestelmä; Système de ballonnet intragastrique; Magenballonsystem; Σύστημα ενδογαστρικού μπαλονιού; Intragasztrikus ballon rendszer; Sistem Balon Intragastrik; Sistema di palloncino intragastrico; Kuņģa balona sistēma; Intragastrinio baliono sistema; Intragastrisk ballongsystem; System balonu żołądkowego; Sistema de balão intragástrico; Sistem cu balonaș intragastric; Система внутрижелудочного баллона; Systém intragastrického balónika; Sistem z intragastričnim balonom; Sistema de balón intragástrico; Intragastriskt ballongsystem; İntragastrik Balon Sistemi; Система внутрішньошлункового балона

    Mar 19, 2025

    Product Code B-50012

    Part Number GRF-00377-00R15

  • Vercise™ PC;Vercise Gevia™;Vercise™ DBS;Vercise™ Cartesia™;Bionic Navigator™;Vercise Neural Navigator™;SureTek™;Vercise™;GUIDE™

    System Reference Guides

    Deep Brain Stimulation System

    May 21, 2025

    Product Code DB-1200, DB-2201-30DC, DB-2201-45DC, DB-2201-30AC, DB-2201-45BC, DB-2202-30, DB-2202-45, NM-3138-55, DB-4600-C, DB-9218-15, DB-9218-55, DB-5132, DB-9315, SC-4108, DB-4108, SC-4100A, DB-4100A, DB-2500-C, DB-4605-C, SC-4252, SC-4254, DB-5552-1A, DB-5250, NM-6210, NM-6600, DB-64125, DB-6300-C, DB-6200-C, DB-6100-C, NM-6350, NM-5312, NM-5305, NM-6305, DB-7161, NM-7161, DB-7161-R, NM-7161-R, DB-7161-203, DB-7161-203-R, DB-7105-N2, NM-7190, DB-7190, NM-6316, DB-7162, NM-7162, NM-7113, NM-6317, DB-7154, DB-7104, DB-7114, DB-7124, DB-1140, DB-9418-15, DB-1110-C, DB-5110-C, DB-5500-C, DB-6412-EU-C, DB-5212-C, NM-3100, DB-7101-203, NM-4500, DB-4511, NM-4502

    Part Number 91030637-12 Rev C

    Applicable To Boston Scientific DBS - Reference Guide

  • SureTek™

    Instructions for Use

    SureTek™ Burr Hole Cover

    May 15, 2025

    Product Code DB-4600-C; DB-4605-C

    Part Number 91062297-02 AC

    Applicable To SureTek™ Burr Hole Cover DFU

    Safety Related Revision No

  • Vercise™ PC;Vercise Gevia™;Vercise™ DBS;Vercise Neural Navigator™

    Instructions for Use

    Programming Wand

    May 15, 2025

    Product Code DB-7190; NM-7190

    Part Number 91169580-02 C

    Applicable To Vercise™ DBS Programming Wand DFU

    Safety Related Revision No

  • Vercise™;Vercise Gevia™;Vercise Genus™

    Instructions for Use;Patient Information

    Charging System

    May 22, 2025

    Product Code DB-64125; DB-6300-C; DB-6200-C; DB-6100-C; NM-6350; NM-5312; NM-5305; NM-6305; NM-6358-SP

    Part Number 91171709-15A

    Applicable To Vercise™ DBS Charging Handbook

    Safety Related Revision Blank

  • Vercise™ PC;ImageReady™;Vercise Gevia™;Vercise™ DBS

    Instructions for Use

    Remote Control 3

    May 15, 2025

    Product Code DB-5552-1A; DB-5250; NM-6210; NM-6315; DB-6315

    Part Number 91172931-02 C

    Applicable To Vercise™ Remote Control 3 DFU

    Safety Related Revision No

  • ImageReady™;Vercise Gevia™;Vercise™ Cartesia™;Vercise Genus™;SureTek™;Vercise™

    MRI Information;Instructions for Use

    MRI Guidelines for Deep Brain Stimulation System

    May 22, 2025

    Product Code DB-9218-15; DB-9218-55; DB-2202-30; DB-2202-45; DB-2201-30DC; DB-2201-45DC; DB-2201-30AC; DB-2201-45BC; DB-4600-C; DB-4605-C; DB-2500-C; NM-3138-55; DB-3128-95; DB-3128-55; DB-1408; DB-1416; DB-1432; DB-1216; DB-1232; SC-4401; DB-1200; DB-5552-1A; DB-5250; DB-5572-1A; DB-5270

    Part Number 92328636-10B

    Applicable To ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems

    Safety Related Revision No

  • Vercise Gevia™;Vercise Genus™

    Instructions for Use;Patient Information

    Charging System with Belt

    May 22, 2025

    Product Code DB-64126; DB-6358-0BK; DB-6358-1BK; DB-6358-5BK; DB-6358-9BK; NM-6350; NM-5312; NM-5305; NM-6305; NM-6358-SP

    Part Number 92357527-06 A

    Applicable To Vercise™ DBS Charging System with Belt- Charging Handbook

    Safety Related Revision No

  • Vercise Genus™;ImageReady™;Vercise™

    Instructions for Use

    Remote Control 4

    May 22, 2025

    Product Code DB-5572-1A; DB-5572-1; DB-5270; DB-6386; NM-6210; DB-6315; NM-6315; NM-6310

    Part Number 92378769-03A

    Applicable To Vercise™ Remote Control 4 - Directions for Use

    Safety Related Revision No

  • Vercise™ PC;Vercise Gevia™;ImageReady™;Vercise Genus™;Vercise™ Cartesia™;SureTek™

    Instructions for Use

    Implantable Pulse Generator; Surgical Implantation of Deep Brain Stimulation Systems

    May 15, 2025

    Product Code DB-1416; DB-1216; DB-1432; DB-1232; DB-1200; DB-1140; DB-2201-30DC; DB-2201-45DC; DB-2202-30; DB-2202-45; DB-4600-C; NM-3138-55; DB-3128-95; DB-3128-55; DB-2500-C; DB-4605-C; DB-5170; DB-5132; DB-4120-08; DB-4100A; SC-4100A; DB-9315; SC-4401; SC-4252; DB-4252; SC-4254; DB-4254; SC-4275

    Part Number 92495783-03 A

    Applicable To Vercise™ DBS Systems - Surgical Implant Manual

    Safety Related Revision No

  • ELUVIA™

    Instructions for Use

    Drug-Eluting Vascular Stent System

    Nov 29, 2024

    Product Code H74939295600470; H74939295600670; H74939295600870; H74939295601070; H74939295601270; H74939295601570; H74939295600410; H74939295600610; H74939295600810; H74939295601010; H74939295601210; H74939295601510; H74939295700470; H74939295700670; H74939295700870; H74939295701070; H74939295701270; H74939295701570; H74939295700410; H74939295700610; H74939295700810; H74939295701010; H74939295701210; H74939295701510

    Part Number 51130986-01B

  • ELUVIA™

    Instructions for Use

    Drug-Eluting Vascular Stent System

    Nov 28, 2024

    Product Code H74939295600470; H74939295600670; H74939295600870; H74939295601070; H74939295601270; H74939295601570; H74939295600410; H74939295600610; H74939295600810; H74939295601010; H74939295601210; H74939295601510; H74939295700470; H74939295700670; H74939295700870; H74939295701070; H74939295701270; H74939295701570; H74939295700410; H74939295700610; H74939295700810; H74939295701010; H74939295701210; H74939295701510; 08714729876755; 08714729876762; 08714729876779; 08714729876786; 08714729876793; 08714729876809; 08714729876816; 08714729876823; 08714729876830; 08714729876847; 08714729876854; 08714729876861; 08714729876878; 08714729876885; 08714729876892; 08714729876908; 08714729876915; 08714729876922; 08714729876939; 08714729876946; 08714729876953; 08714729876960; 08714729876977; 08714729876984

    Part Number 51438473-01A

  • Innova™

    Instructions for Use

    Self-Expanding Stent System

    Mar 17, 2025

    Product Code H74939180050270; H74939180051070; H74939180051270; H74939180051570; H74939180051870; H74939180052070; H74939180054070; H74939180056070; H74939180058070; H74939180060270; H74939180061070; H74939180061270; H74939180061570; H74939180061870; H74939180062070; H74939180064070; H74939180066070; H74939180068070; H74939180070270; H74939180071070; H74939180071270; H74939180071570; H74939180071870; H74939180072070; H74939180074070; H74939180076070; H74939180078070; H74939180080270; H74939180081070; H74939180081270; H74939180081570; H74939180081870; H74939180082070; H74939180084070; H74939180086070; H74939180088070; H74939181050230; H74939181051030; H74939181051230; H74939181051530; H74939181051830; H74939181052030; H74939181054030; H74939181056030; H74939181058030; H74939181060230; H74939181061030; H74939181061230; H74939181061530; H74939181061830; H74939181062030; H74939181064030; H74939181066030; H74939181068030; H74939181070230; H74939181071030; H74939181071230; H74939181071530; H74939181071830; H74939181072030; H74939181074030; H74939181076030; H74939181078030; H74939181080230; H74939181081030; H74939181081230; H74939181081530; H74939181081830; H74939181082030; H74939181084030; H74939181086030; H74939181088030; 08714729792062; 08714729792079; 08714729792086; 08714729792093; 08714729792109; 08714729792116; 08714729792123; 08714729792130; 08714729792147; 08714729792154; 08714729792161; 08714729792178; 08714729792185; 08714729792192; 08714729792208; 08714729792215; 08714729792222; 08714729792239; 08714729792246; 08714729792253; 08714729792260; 08714729792277; 08714729792284; 08714729792291; 08714729792307; 08714729792314; 08714729792321; 08714729792338; 08714729792345; 08714729792352; 08714729792369; 08714729792376; 08714729792383; 08714729792390; 08714729792406; 08714729792413; 08714729792420; 08714729792437; 08714729792444; 08714729792451; 08714729792468; 08714729792475; 08714729792482; 08714729792499; 08714729792505; 08714729792512; 08714729792529; 08714729792536; 08714729792543; 08714729792550; 08714729792567; 08714729792574; 08714729792581; 08714729792598; 08714729792604; 08714729792611; 08714729792628; 08714729792635; 08714729792642; 08714729792659; 08714729792666; 08714729792673; 08714729792680; 08714729792697; 08714729792703; 08714729792710; 08714729792727; 08714729792734; 08714729792741; 08714729792758; 08714729792765; 08714729792772

    Part Number 51188989-01B

  • Innova™

    Instructions for Use

    Self-Expanding Stent System

    Mar 19, 2025

    Product Code H74939180050270; H74939180051070; H74939180051270; H74939180051570; H74939180051870; H74939180052070; H74939180054070; H74939180056070; H74939180058070; H74939180060270; H74939180061070; H74939180061270; H74939180061570; H74939180061870; H74939180062070; H74939180064070; H74939180066070; H74939180068070; H74939180070270; H74939180071070; H74939180071270; H74939180071570; H74939180071870; H74939180072070; H74939180074070; H74939180076070; H74939180078070; H74939180080270; H74939180081070; H74939180081270; H74939180081570; H74939180081870; H74939180082070; H74939180084070; H74939180086070; H74939180088070; H74939181050230; H74939181051030; H74939181051230; H74939181051530; H74939181051830; H74939181052030; H74939181054030; H74939181056030; H74939181058030; H74939181060230; H74939181061030; H74939181061230; H74939181061530; H74939181061830; H74939181062030; H74939181064030; H74939181066030; H74939181068030; H74939181070230; H74939181071030; H74939181071230; H74939181071530; H74939181071830; H74939181072030; H74939181074030; H74939181076030; H74939181078030; H74939181080230; H74939181081030; H74939181081230; H74939181081530; H74939181081830; H74939181082030; H74939181084030; H74939181086030; H74939181088030

    Part Number 51438005-01A

  • rezūm™

    Instructions for Use

    Delivery Device Kit for BPH

    Apr 22, 2021

    Product Code D2201-003

    Part Number 3032-004

  • rezūm™

    Instructions for Use

    Generator

    Apr 22, 2021

    Product Code G2200-0031

    Part Number 3033-001

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