Medtronic Vascular, Inc.

FDA Regulatory Profile

Summary

Total Recalls
230 (204 Class I)
510(k) Clearances
480
Inspections
23
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1042-2022Class IIMedtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the folloMarch 23, 2022
Z-1043-2022Class IIMedtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx OnlyMarch 23, 2022
Z-0657-2022Class IIEndurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System December 21, 2021
Z-0292-2022Class IIEndurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IISOctober 15, 2021
Z-0291-2022Class IIEndurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BOctober 15, 2021
Z-0290-2022Class IIEndurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBEOctober 15, 2021
Z-2135-2021Class IIEndurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF321June 7, 2021
Z-2136-2021Class IIMedtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614CJune 7, 2021
Z-1860-2021Class IAngiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiMay 4, 2021
Z-1976-2021Class IIEndurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vasculApril 28, 2021
Z-1201-2021Class IValiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thFebruary 12, 2021
Z-1246-2021Class IIMedtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40January 15, 2021
Z-1248-2021Class IIMedtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30January 15, 2021
Z-1247-2021Class IIMedtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375January 15, 2021
Z-1245-2021Class IIMedtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35January 15, 2021
Z-0089-2021Class IRashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product numberAugust 25, 2020
Z-0088-2021Class IRashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product numberAugust 25, 2020
Z-0087-2021Class IRashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single LumenAugust 25, 2020
Z-2655-2019Class ISHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0, .070", REF SA6CHAMP20. for cardiovascular useMarch 15, 2019
Z-2606-2019Class ISHERPA NX ACTIVE GUIDING CATHETER, 6F, RDC, 55CM, 070", REF SA6RDCK. for cardiovascular useMarch 15, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K232570Steerant™ Super Stiff GuidewireOctober 24, 2023
K2321906F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterAugust 22, 2023
K2301565F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher GuidJune 30, 2023
K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way StopcoApril 13, 2022
K192296Medtronic 6F Taiga Guiding CatheterSeptember 20, 2019
K182957Heli-FX EndoAnchor SystemNovember 21, 2018
K173515Admiral XtremeApril 12, 2018
K171866Sentrant Introducer Sheath with Hydrophilic CoatingDecember 20, 2017
K170191SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemJune 16, 2017
K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteJune 13, 2017
K162097InTRAkitNovember 17, 2016
K162027TRAcelet Compression DeviceOctober 21, 2016
K161361HawkOne Directional Atherectomy SystemOctober 14, 2016
K161287DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZAugust 19, 2016
K133539TOTAL ACROSSMarch 26, 2014
K123990SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATINGApril 26, 2013
K123358PACIFIC PLUSJanuary 29, 2013
K101777PIONEER PLUS CATHETER, MODEL PLUS 120July 23, 2010
K091582GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15December 4, 2009
K0834226F TAIGA GUIDING CATHETERFebruary 6, 2009