Medtronic, Inc.
Medtronic, Inc. holds FDA 510(k) medical device clearances, first cleared 1981, most recent 2026, with 113 FDA device recalls on record.
Top product codes for Medtronic, Inc.
FDA recalls by Medtronic, Inc.
10 most recent of 113- Z-0302-2027 — CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable
- Z-0303-2027 — CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable
- Z-0304-2027 — CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable
- Z-0285-2027 — OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter delivered, transvenous ventricular lead with an RV defibrillation coil electrode. The lead is designed for pacing, sensing, cardioversion, and defibrillation therapies.
- Z-1948-2026 — Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
- Z-1098-2026 — Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
- Z-0726-2026 — Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
- Z-2169-2025 — Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
- Z-2168-2025 — Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;
- Z-2128-2025 — Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model Number D00U005; 4. Micra VR application, Software Model Number D00U006; 5. Micra AV application, Software Model Number D00U007; 6. Viva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; 7. Claria Amplia Compia application, Software Model Number D00U009; 8. Evera MRI application, Software Model Number D00U010; 9. Visia AF application, Software Model Number D00U011; 10. Viva Brava Evera application, Software Model Number D00U012; 11. Micra VR2 AV2 application, Software Model Number D00U022.
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, Inc.
1–100 of 215- K263596 — DLP Coronary Ostial Cannulae
- K262913 — Protégé EverFlex Self-expanding Peripheral Stent System
- K262735 — LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
- K262005 — Affera Integrated Mapping System
- K261335 — VitalFlow Set with Balance Biosurface
- K261866 — Concerto Versa Detachable Coil
- K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae
- K253203 — Retrograde Coronary Sinus Perfusion Cannulae
- K253998 — Clearview Intracoronary Shunts
- K251831 — Bio-Medicus Life Support Catheter and Introducer
- K253511 — Concerto Versa Detachable Coil
- K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
- K251258 — MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula
- K250075 — Medtronic Stedi Extra Support Guidewire
- K250199 — VitalFlow Console
- K250558 — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
- K242705 — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
- K243892 — Affera Integrated Mapping System
- K243435 — Magnetic Localization Patch Kit (AFR-00021)
- K241828 — Affera Integrated Mapping System; Impedance Localization Patch Kit
- K240880 — VitalFlow Set with Balance Biosurface
- K241352 — Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541) +1 more
- K241259 — Amplatz Goose Neck Snare Kit
- K240534 — Bio-Medicus Life Support Catheter and Introducer
- K233838 — Emprint Ablation System with Thermosphere Technology (Overall System Name) +9 more
- K240693 — LINQ II Insertable Cardiac Monitor (ICM)
- K233943 — Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
- K231206 — DLP Silicone Coronary Artery Ostial Cannulae
- K233562 — LINQ II Insertable Cardiac Monitor
- K233397 — Cosine-10TM Diagnostic Catheter
- K232321 — FlexCath Contour Steerable Sheath
- K233320 — LINQ II Insertable Cardiac Monitor (LNQ22)
- K230960 — DLP Silicone Coronary Artery Ostial Cannulae
- K230553 — LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
- K223168 — Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface
- K230640 — Affinity Fusion Oxygenator System
- K223630 — Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
- K223488 — ClosureFast Endovenous Radiofrequency Ablation Catheter
- K223508 — Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
- K221962 — LINQ II Insertable Cardiac Monitor
- K201057 — Bio-Medicus Life Support Catheter and Introducer
- K213631 — Chocolate PTA Balloon Catheter
- K212027 — TurboHawk Plus Directional Atherectomy System
- K212008 — Reveal LINQ Insertable Cardiac Monitor
- K201100 — Bio-Medicus Life Support Catheter and Introducer
- K203556 — Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
- K210484 — LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
- K211304 — LINQ II Insertable Cardiac Monitor
- K211057 — LigaPASS® Spinal System, CD Horizon Spinal System
- K192712 — Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter
- K200795 — LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit
- K201449 — SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
- K201118 — Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
- K201068 — Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
- K201011 — Medtronic Model 5392 External Pulse Generator (EPG)
- K200074 — O-arm O2 Imaging System
- K200630 — Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
- K192636 — TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
- K192389 — TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
- K200456 — Becker External Drainage and Monitoring System
- K191526 — Cardioblate CryoFlex Surgical Ablation System
- K191444 — Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir
- K190574 — Patient Assistant Model PA97000
- K191077 — Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor
- K191029 — Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac
- K190825 — Medtronic Model 5392 External Pulse Generator (EPG)
- K183490 — Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface
- K190557 — Bio-Medicus Insertion Kit
- K183353 — Telescope Guide Extension Catheter
- K183511 — Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241)
- K183493 — SelectSite C304-HIS Deflectable Catheter System
- K181918 — CardioInsight Cardiac Mapping System
- K182586 — DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port
- K181973 — Medtronic Model 5392 External Pulse Generator (EPG)
- K180122 — TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)
- K180030 — TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
- K180873 — Medtronic Model 53401 External Pulse Generator (EPG)
- K180453 — Bio-Medicus Adult Cannulae and Introducer
- K180456 — Bio-Medicus Adult Cannulae Kit
- K173664 — Medtronic O-arm O2 Imaging System
- K172984 — Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface
- K171979 — Tubing Pack
- K172626 — Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir
- K171308 — Tubing Pack
- K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
- K163008 — CareLink SmartSync Device Manager - Pacing System Analyzer
- K163032 — Kyphon Xpede Bone Cement
- K162855 — Reveal LINQ
- K163460 — Reveal LINQ Insertable Cardiac Monitor
- K162774 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)
- K162958 — MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface +3 more
- K162896 — Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
- K162892 — Achieve Advance Mapping Catheter
- K162054 — Medtronic Temporary External Pacemaker 53401
- K162550 — Medtronic Model 5392 External Pulse Generator (EPG)
- K162016 — Affinity NT Oxygenator with Cortiva BioActive Surface
- K160983 — Kyphon HV-R Bone Cement
- K160809 — Reveal LINQ
- K160091 — Temperature Probe, Affinity Temperature Probe
- K153139 — Achieve ST Mapping Catheter, Catheter Connecting Cable
Data sourced from openFDA. This site is unofficial and independent of the FDA.