Introducer, catheter
FDA product code DYB · Class 2 · 1,311 devices · 18,780 reports · 263 deaths reported · 203 devices named in recalls
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
- Edwards eSheath+ Introducer set 916ESPEdwards Lifesciences LLC · Introducer, Catheter18 deaths298 reports
- GORE DRYSEAL FLEX Introducer Sheath DSF2233W. L. Gore & Associates, Inc. · INTRODUCER, CATHETER8 deaths297 reports
- iSLEEVE™ H74939349140Boston Scientific Corporation · INTRODUCER, CATHETER1 recall12 deaths243 reports
- CARTO VIZIGO D138504Biosense Webster Inc · Introducer, catheter2 deaths288 reports
- Swartz™ 407453St. Jude Medical, Inc. · INTRODUCER, CATHETER4 deaths287 reports
- Fast-Cath™ 406303St. Jude Medical, Inc. · INTRODUCER, CATHETER1 recall226 reports
- Agilis™ 408310St. Jude Medical, Inc. · INTRODUCER, CATHETER2 deaths218 reports
- Agilis™ 408309St. Jude Medical, Inc. · INTRODUCER, CATHETER1 recall3 deaths166 reports
- GLIDESHEATH SLENDER 80-1060Terumo Medical Corporation · INTRODUCER, CATHETER192 reports
- Micra™ Introducer MI2355AMedtronic, Inc. · INTRODUCER, CATHETER31 deaths188 reports
- GLIDESHEATH SLENDER 60-1060Terumo Medical Corporation · INTRODUCER, CATHETER1 recall107 reports
- GORE DRYSEAL FLEX Introducer Sheath DSF2433W. L. Gore & Associates, Inc. · INTRODUCER, CATHETER7 deaths152 reports
- PREFACE 301803MBiosense Webster Inc · INTRODUCER, CATHETER1 death152 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-SSt. Jude Medical, Inc. · Introducer, catheter151 reports
- R2P Destination Slender GS-R6ST1C12WTerumo Medical Corporation · INTRODUCER, CATHETER145 reports
- Impella 1000550Abiomed, Inc. · Introducer, Catheter1 recall10 deaths92 reports
- GORE DRYSEAL FLEX Introducer Sheath DSF1633W. L. Gore & Associates, Inc. · INTRODUCER, CATHETER3 deaths135 reports
- Introducer Kit for Impella® 0052-3006Oscor Inc. · INTRODUCER, CATHETER2 recalls4 deaths33 reports
- Swartz™ 407449St. Jude Medical, Inc. · INTRODUCER, CATHETER3 deaths130 reports
- Flexor G44154Cook Incorporated · INTRODUCER, CATHETER1 recall1 death73 reports
- Agilis™ G408324St. Jude Medical, Inc. · INTRODUCER, CATHETER120 reports
- Fast-Cath™ 406143St. Jude Medical, Inc. · INTRODUCER, CATHETER1 recall69 reports
- Introducer Kit for Impella® 0052-3021Oscor Inc. · INTRODUCER, CATHETER2 recalls17 reports
- Swartz™ 407439St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths115 reports
- Guidestar™ Steerable Guiding Sheath D141103Oscor Inc. · INTRODUCER, CATHETER1 recall1 death60 reports
- ARROW IPN036821Teleflex Incorporated · INTRODUCER, CATHETER2 recalls8 reports
- Rosch-Uchida G06929Cook Incorporated · INTRODUCER, CATHETER1 recall55 reports
- EDWARDS ESHEATH INTRODUCER SET 914ESEdwards Lifesciences LLC · Introducer, Catheter6 deaths104 reports
- ARROW IPN036830Teleflex Incorporated · INTRODUCER, CATHETER2 recalls3 reports
- ARROW IPN036452Teleflex Incorporated · INTRODUCER, CATHETER2 recalls3 reports
- Fast-Cath™ 406840St. Jude Medical, Inc. · INTRODUCER, CATHETER2 deaths102 reports
- ARROW IPN036824Teleflex Incorporated · INTRODUCER, CATHETER2 recalls2 reports
- Reinforced Introducer Set for Sensation Plus & Mega 8Fr 0684-00-0403-10Datascope Corp. · Introducer, Catheter2 recalls1 report
- ARROW IPN037022Teleflex Incorporated · INTRODUCER, CATHETER2 recalls1 report
- ARROW IPN039122Teleflex Incorporated · INTRODUCER, CATHETER2 recalls1 report
- ARROW IPN036838Teleflex Incorporated · INTRODUCER, CATHETER2 recalls1 report
- ARROW IPN036446Teleflex Incorporated · INTRODUCER, CATHETER2 recalls1 report
- Prelude Roadster™ 00884450770757Merit Medical Systems, Inc. · Introducer, catheter2 recalls0 reports
- Prelude Roadster™ 00884450770771Merit Medical Systems, Inc. · Introducer, catheter2 recalls0 reports
- Reinforced Introducer Set for Linear 7.5Fr & Mega 7.5Fr 0684-00-0403-05Datascope Corp. · Introducer, Catheter2 recalls0 reports
- Reinforced Introducer Set for Sensation 7Fr 0684-00-0403-06Datascope Corp. · Introducer, Catheter2 recalls0 reports
- ARROW IPN037258Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN037025Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN037610Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN029661Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN039798Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN921749Teleflex Incorporated · INTRODUCER, CATHETER2 recalls0 reports
- ARROW IPN926611Teleflex Incorporated · Introducer, catheter2 recalls0 reports
- ARROW IPN929229Teleflex Incorporated · Introducer, catheter2 recalls0 reports
- Agilis™ G408319St. Jude Medical, Inc. · INTRODUCER, CATHETER97 reports
- GORE DRYSEAL FLEX Introducer Sheath DSF1233W. L. Gore & Associates, Inc. · INTRODUCER, CATHETER1 death92 reports
- Performer G08957Cook Incorporated · INTRODUCER, CATHETER1 recall3 deaths41 reports
- ULTIMUM™ 407831St. Jude Medical, Inc. · INTRODUCER, CATHETER1 recall40 reports
- Flexor G44155Cook Incorporated · INTRODUCER, CATHETER1 recall37 reports
- Flexor G47701Cook Incorporated · INTRODUCER, CATHETER1 recall37 reports
- GORE DRYSEAL FLEX Introducer Sheath DSF1833W. L. Gore & Associates, Inc. · INTRODUCER, CATHETER4 deaths86 reports
- Fast-Cath™ 406968St. Jude Medical, Inc. · INTRODUCER, CATHETER84 reports
- Introducer Kit for Impella® 0052-3025Oscor Inc. · INTRODUCER, CATHETER1 recall1 death32 reports
- Micropuncture G47944Cook Incorporated · INTRODUCER, CATHETER78 reports
- Micropuncture G48003Cook Incorporated · INTRODUCER, CATHETER78 reports
- GORE DRYSEAL FLEX Introducer Sheath DSF2033W. L. Gore & Associates, Inc. · INTRODUCER, CATHETER1 death77 reports
- Prelude SNAP™ 10884450467982Merit Medical Systems, Inc. · INTRODUCER, CATHETER1 recall19 reports
- Flexor G11638Cook Incorporated · INTRODUCER, CATHETER65 reports
- Flexor G56231Cook Incorporated · INTRODUCER, CATHETER65 reports
- TorFlex Transseptal Guiding Sheath TF85-32-63-45Boston Scientific Corporation · Introducer, Catheter1 recall12 reports
- Flexor G29982Cook Incorporated · INTRODUCER, CATHETER62 reports
- Flexor G56279Cook Incorporated · INTRODUCER, CATHETER1 recall12 reports
- CARTO VIZIGO D138505Biosense Webster Inc · Introducer, catheter61 reports
- Halo One™ Thin-Walled Guiding Sheath HLO54535Clearstream Technologies Limited · INTRODUCER, CATHETER60 reports
- Introducer Kit for Impella® 0052-3025Oscor Inc. · INTRODUCER, CATHETER1 recall10 reports
- Flexor G13081Cook Incorporated · INTRODUCER, CATHETER1 recall9 reports
- Ring G29769Cook Incorporated · INTRODUCER, CATHETER1 recall7 reports
- Flexor G32233Cook Incorporated · INTRODUCER, CATHETER1 recall7 reports
- Swartz™ 407362St. Jude Medical, Inc. · INTRODUCER, CATHETER56 reports
- ARROW IPN036826Teleflex Incorporated · INTRODUCER, CATHETER1 recall6 reports
- Prelude SNAP™ 10884450467951Merit Medical Systems, Inc. · INTRODUCER, CATHETER1 recall6 reports
- DESTINATION RSR01Terumo Medical Corporation · INTRODUCER, CATHETER55 reports
- Impella 1000441Abiomed, Inc. · Introducer, Catheter1 recall5 reports
- ARROW IPN036444Teleflex Incorporated · INTRODUCER, CATHETER1 recall5 reports
- Flexor G36393Cook Incorporated · INTRODUCER, CATHETER1 recall4 reports
- ARROW IPN036979Teleflex Incorporated · INTRODUCER, CATHETER1 recall4 reports
- Flexor G12266Cook Incorporated · INTRODUCER, CATHETER1 death53 reports
- Flexor G12606Cook Incorporated · INTRODUCER, CATHETER1 recall3 reports
- Flexor G13033Cook Incorporated · INTRODUCER, CATHETER1 recall3 reports
- Flexor G32373Cook Incorporated · INTRODUCER, CATHETER1 recall3 reports
- Flexor G49101Cook Incorporated · INTRODUCER, CATHETER1 recall3 reports
- ARROW IPN036335Teleflex Incorporated · INTRODUCER, CATHETER1 recall3 reports
- ARROW IPN929678Teleflex Incorporated · Introducer, catheter1 recall3 reports
- NA 6207-S1Medtronic, Inc. · INTRODUCER, CATHETER2 deaths52 reports
- Halo One™ Thin-Walled Guiding Sheath HAL545Clearstream Technologies Limited · INTRODUCER, CATHETER1 recall2 reports
- Check-Flo G08686Cook Incorporated · INTRODUCER, CATHETER1 recall2 reports
- Flexor G13160Cook Incorporated · INTRODUCER, CATHETER1 recall2 reports