Abbott Vascular
Abbott Vascular holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2022, with 37 FDA device recalls on record.
Top product codes for Abbott Vascular
FDA recalls by Abbott Vascular
10 most recent of 37- Z-0116-2023 — Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW, MitraClip G4 Clip Delivery System XT CE/CDS0702-XT, MitraClip G4 Clip Delivery System XTW CE/CDS0702-XTW, MitraClip G4 Clip Delivery Sys NT ROW/CDS0705-NT, MitraClip G4 Clip Delivery Sys NTW ROW/CDS0705-NTW, MitraClip G4 Clip Delivery Sys XT ROW/CDS0705-XT, MitraClip G4 Clip Delivery Sys XTW ROW/CDS0705-XTW, TriClip XT Clip Delivery Sys CE/TCDS0202-XT, TriClip NT Clip Delivery Sys CE/TCDS0202-NT, TriClip XT Clip Delivery Sys ROW/TCDS0205-XT, TriClip NT Clip Delivery Sys ROW/TCDS0205-NT, TriClip G4 NT Delivery System CE/TCDS0302-NT, TriClip G4 NTW Delivery System CE/TCDS0302-NTW, TriClip G4 XT Delivery System CE/TCDS0302-XT, TriClip G4 XTW Delivery System CE/TCDS0302-XTW, TriClip G4 NT Delivery System ROW/TCDS0305-NT, TriClip G4 NTW Delivery System ROW/TCDS0305-NTW, TriClip G4 XT Delivery System ROW/TCDS0305-XT, TriClip G4 XTW Delivery System ROW/TCDS0305-XTW, TriClip NT Clip Delivery Sys CE/TCDS0202-NT, TriClip NT Clip Delivery Sys ROW/TCDS0205-NT. For cardiac procedures.
- Z-0115-2023 — Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW US/CDS0701-XTW. For cardiac procedures.
- Z-0117-2023 — Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT, TriClip G4 NT Delivery System CLIN/TCDS0303-NT, TriClip G4 NTW Delivery System CLIN/TCDS0303-NTW, TriClip G4 XT Delivery System CLIN/TCDS0303-XT, TriClip G4 XTW Delivery System CLIN/TCDS0303-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT. For cardiac procedures.
- Z-1095-2022 — Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
- Z-0922-2022 — 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV - REF 1000186-115 WPL2122270-02 (2019-03-01)
- Z-0923-2022 — 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)
- Z-0921-2022 — 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
- Z-0924-2022 — INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
- Z-0925-2022 — Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-01 (2019-03-01)
- Z-2370-2020 — Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g; Lot number 903224A,
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 Abbott Vascular
- K220634 — NC TREK NEO Coronary Dilatation Catheter
- K221057 — Viatrac 14 Plus Peripheral Dilatation Catheter
- K201834 — HI-TORQUE PROCEED Guide Wire Family
- K200144 — HI-TORQUE Steelcore Bare Guide Wire
- K193126 — HI-TORQUE InfilTrac Guide Wire Family
- K191173 — Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
- K180040 — NC TREK RX Coronary Dilatation Catheter +6 more
- K173795 — HI-TORQUE TurnTrac Guide Wire Family
- K172394 — Steerable Guide Catheter
- K172073 — Hi-Torque Command 18 Guide Wire
- K161985 — Steerable Guide Catheter
- K153086 — RX ACCUNET Embolic Protection System
- K152709 — HI-TORQUE BALANCE
- K152404 — Hi-Torque Command 18 Guide Wire
- K151317 — Armada 18 PTA Catheter
- K141782 — HI-TORQUE VERSATURN GUIDE WIRE
- K141678 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
- K123279 — MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
- K121352 — ARMADA 14XXT PTA CATHETER
- K121222 — TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
- K121015 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
- K113464 — NC TREK OTW CORONARY DILATATION CATHETER
- K111899 — ARMADA 35/35LL PTA CATHETER
- K112239 — STEERABLE GUIDE CATHETER
- K110617 — MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER
- K092286 — FOX SV PTA CATHETER
- K083738 — HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05
- K083732 — TAD AND TAD II TAPERED GUIDE WIRES
- K083713 — .035 LOC GUIDE WIRE EXTENSION
- K083706 — HI-TORQUE VERSACORE GUIDE WIRE
Data sourced from openFDA. This site is unofficial and independent of the FDA.