Medtronic Vascular
Medtronic Vascular holds FDA 510(k) medical device clearances, first cleared 1977, most recent 2023, with 211 FDA device recalls on record.
Top product codes for Medtronic Vascular
FDA recalls by Medtronic Vascular
10 most recent of 211- Z-1860-2021 — Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire components associated with this recall are manufactured with a requirement that further downstream processing (sterilization) is required. Indications for use for these components are not defined as they are not intended for final use.
- Z-1245-2021 — Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
- Z-1247-2021 — Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
- Z-1248-2021 — Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30
- Z-1246-2021 — Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
- Z-0089-2021 — Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.
- Z-0088-2021 — Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.
- Z-0087-2021 — Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a treatment option for patients with a Cyanotic Congenital heart defect. Cyanotic congenital heart defects are rare conditions that are associated with high morbidity and mortality.
- Z-2681-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070", REF SA6SL50. for cardiovascular use
- Z-2641-2019 — SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardiovascular use
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Medtronic Vascular
1–100 of 475- K232570 — Steerant Super Stiff Guidewire
- K232190 — 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
- K230156 — 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
- K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more
- K192296 — Medtronic 6F Taiga Guiding Catheter
- K173515 — Admiral Xtreme
- K162097 — InTRAkit
- K162027 — TRAcelet Compression Device
- K161287 — DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
- K133539 — TOTAL ACROSS
- K123990 — SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
- K123358 — PACIFIC PLUS
- K101777 — PIONEER PLUS CATHETER, MODEL PLUS 120
- K091582 — GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
- K082873 — MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
- K083422 — 6F TAIGA GUIDING CATHETER
- K081573 — MEDTRONIC EXPORT AP CATHETER
- K062264 — COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
- K071253 — AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
- K070288 — CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814
- K070311 — CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261
- K061416 — SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74
- K062727 — CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
- K062420 — 5F SHERPA ACTIVE NX GUIDE CATHETER
- K061958 — MEDTRONIC EXPORT XT CATHETER
- K062057 — U-CLIP DEVICE, MODEL NC65
- K061127 — CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
- K060418 — 8F SHERPA NX GUIDE CATHETER
- K052459 — 6248VAL ADJUSTABLE VALVE
- K051386 — MASTERGRAFT PUTTY BONE VOID FILLER
- K053252 — U-CLIP DEVICE, MODELS B140, B160 AND B180
- K052413 — TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
- K051846 — 7F SHERPA NX GUIDE CATHETER
- K050139 — MODIFICATION TO: EXPORT CATHETER
- K043291 — CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
- K042489 — 6F Z4 GUIDE CATHETER
- K043080 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
- K042175 — HEPARINASE HR ACT CONTROL, MODEL 550-12
- K042206 — PURPLE/BLACK HEPARIN ASSAY CONTROL
- K042070 — HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
- K042194 — ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY
- K042190 — MODEL 6416 TEMPORARY PACING LEAD SYSTEM
- K040812 — DETECT SURGICAL PACING AND MAPPING TOOL
- K041244 — POLYGRAM NET BIOFEEDBACK APPLICATION
- K041338 — MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
- K040869 — EXPORT CATHETER
- K033540 — TRANSXCHANGE SUPPORT CATHETER
- K033050 — EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2
- K040568 — POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
- K034058 — SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
- K032312 — ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
- K032926 — EKG SPEAKS
- K032138 — MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER
- K032561 — RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR
- K032622 — ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS
- K030671 — MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB
- K031211 — ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH
- K031247 — CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM
- K024278 — PACEART SYSTEM
- K031274 — MODEL 5071 MYOCARDIAL PACING LEAD
- K031518 — EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,
- K030779 — 5F MEDTRONIC LAUNCHER GUIDE CATHETER
- K030201 — MODIFICATION TO EXPORT ASPIRATION CATHETER
- K023878 — GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
- K024069 — ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
- K024032 — ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY
- K024035 — ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
- K023402 — 8F LAUNCHER GUIDE CATHETER
- K023303 — EXPORT ASPIRATION CATHETER
- K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
- K021804 — PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM; PROVU TUNA SYSTEM
- K022764 — 7F LAUNCHER GUIDE CATHETER
- K021902 — MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300
- K021587 — ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A
- K021589 — ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218
- K021256 — Z3 GUIDE CATHETER
- K013517 — 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
- K013963 — MODEL 9210 DELIVERY CATHETER, MODEL 9210
- K013392 — CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880
- K010579 — STENT SUPPORT GUIDE CATHETER
- K012083 — ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
- K012130 — ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM
- K012225 — ATTAIN 6215 VENOGRAM BALLOON CATHETER
- K012538 — TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
- K012452 — MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
- K012454 — MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
- K012458 — MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
- K012459 — MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
- K012460 — MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
- K010300 — MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION
- K011395 — MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
- K011864 — TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
- K011584 — MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF
- K011098 — REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
- K010906 — MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
- K003667 — REVEAL PLUS INSERTABLE LOOP RECORDER
- K003535 — STYLET KIT, MODELS 6254,6282,6293
- K003724 — CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
- K001969 — GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
- K000955 — PLACER MODEL 6232 STEERABLE STYLET
Data sourced from openFDA. This site is unofficial and independent of the FDA.