Company · US
Medtronic, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2026. Name variants (Inc, Corp, punctuation) are merged.
249510(k) clearances (15 in 12 months)
328recalls (7 in 12 months)
222recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DQY | Catheter, Percutaneous | 163 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 33 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 31 |
| MDS | Sensor, Glucose, Invasive | 24 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 19 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 18 |
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | 18 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 11 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 9 |
| DTE | Pulse-Generator, Pacemaker, External | 8 |
| DSI | Detector And Alarm, Arrhythmia | 7 |
| DYB | Introducer, Catheter | 7 |
| DYE | Replacement Heart-Valve | 7 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 7 |
| NVZ | Pulse Generator, Permanent, Implantable | 7 |
| DQK | Computer, Diagnostic, Programmable | 6 |
| DQX | Wire, Guide, Catheter | 6 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 6 |
| LDF | Electrode, Pacemaker, Temporary | 6 |
| NIK | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2026 | K263596 | DLP Coronary Ostial Cannulae Medtronic, Inc. | DWF |
| Oct 23, 2026 | K261792 | DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent Medtronic | |
| Sep 17, 2026 | K262913 | Protégé EverFlex Self-expanding Peripheral Stent System Medtronic, Inc. | FGE |
| Aug 28, 2026 | K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) Medtronic, Inc. | MXD |
| Aug 21, 2026 | K262005 | Affera Integrated Mapping System Medtronic, Inc. | DQK |
| Jul 31, 2026 | K261335 | VitalFlow Set with Balance Biosurface Medtronic, Inc. | QJZ |
| Jun 24, 2026 | K261866 | Concerto Versa Detachable Coil Medtronic, Inc. | KRD |
| May 28, 2026 | K253530 | Trexon Monofilament Synthetic Absorbable Suture Medtronic | GAM |
| Apr 23, 2026 | K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae Medtronic, Inc. | DWF |
| Feb 19, 2026 | K253203 | Retrograde Coronary Sinus Perfusion Cannulae Medtronic, Inc. | DWF |
| Jan 20, 2026 | K253998 | Clearview Intracoronary Shunts Medtronic, Inc. | DWF |
| Jan 16, 2026 | K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter Medtronic | DTM |
| Jan 15, 2026 | K251831 | Bio-Medicus Life Support Catheter and Introducer Medtronic, Inc. | QHW |
| Jan 14, 2026 | K253511 | Concerto Versa Detachable Coil Medtronic, Inc. | KRD |
| Dec 19, 2025 | K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LB Medtronic, Inc. | DQY |
| Jun 20, 2025 | K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula Medtronic, Inc. | DWF |
| Jun 13, 2025 | K250075 | Medtronic Stedi Extra Support Guidewire Medtronic, Inc. | DQX |
| May 20, 2025 | K250199 | VitalFlow Console Medtronic, Inc. | QNR |
| Mar 27, 2025 | K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) Medtronic, Inc. | DQY |
| Jan 17, 2025 | K243892 | Affera Integrated Mapping System Medtronic, Inc. | DQK |
| Jan 17, 2025 | K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Strea Medtronic, Inc. | LDF |
| Dec 5, 2024 | K243435 | Magnetic Localization Patch Kit (AFR-00021) Medtronic, Inc. | DQK |
| Nov 1, 2024 | K241828 | Affera Integrated Mapping System; Impedance Localization Patch Kit Medtronic, Inc. | DQK |
| Sep 12, 2024 | K240880 | VitalFlow Set with Balance Biosurface Medtronic, Inc. | QJZ |
| Aug 7, 2024 | K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) Medtronic | MTD |
| Jun 12, 2024 | K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface a Medtronic, Inc. | DTZ |
| Jun 3, 2024 | K241259 | Amplatz Goose Neck Snare Kit Medtronic, Inc. | MMX |
| Apr 19, 2024 | K240534 | Bio-Medicus Life Support Catheter and Introducer Medtronic, Inc. | QHW |
| Mar 28, 2024 | K240693 | LINQ II Insertable Cardiac Monitor (ICM) Medtronic, Inc. | MXD |
| Mar 28, 2024 | K233838 | Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Medtronic, Inc. | NEY |
| Mar 8, 2024 | K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) Medtronic, Inc. | DQK |
| Feb 23, 2024 | K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoat Medtronic | DTR |
| Dec 7, 2023 | K231206 | DLP Silicone Coronary Artery Ostial Cannulae Medtronic, Inc. | DWF |
| Dec 6, 2023 | K233562 | LINQ II Insertable Cardiac Monitor Medtronic, Inc. | MXD |
| Dec 2, 2023 | K233397 | Cosine-10TM Diagnostic Catheter Medtronic, Inc. | DRF |
| Oct 31, 2023 | K233320 | LINQ II Insertable Cardiac Monitor (LNQ22) Medtronic, Inc. | MXD |
| Oct 31, 2023 | K232321 | FlexCath Contour Steerable Sheath Medtronic, Inc. | DRA |
| May 4, 2023 | K230960 | DLP Silicone Coronary Artery Ostial Cannulae Medtronic, Inc. | DWF |
| Apr 26, 2023 | K230553 | LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application Medtronic, Inc. | MXD |
| Apr 19, 2023 | K223168 | Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface Medtronic, Inc. | QWF |
| Apr 6, 2023 | K230640 | Affinity Fusion Oxygenator System Medtronic, Inc. | DTZ |
| Apr 5, 2023 | K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System Medtronic, Inc. | MXD |
| Mar 23, 2023 | K223488 | ClosureFast Endovenous Radiofrequency Ablation Catheter Medtronic, Inc. | GEI |
| Jan 23, 2023 | K223494 | CD Horizon Spinal System Medtronic | NKB |
| Dec 22, 2022 | K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device Medtronic, Inc. | OCL |
| Nov 8, 2022 | K223178 | SelectSite C304 Deflectable Catheter System, C315 Delivery System Medtronic | DQY |
| Nov 7, 2022 | K222873 | Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system Medtronic | DQY |
| Aug 25, 2022 | K221962 | LINQ II Insertable Cardiac Monitor Medtronic, Inc. | MXD |
| May 25, 2022 | K221244 | CD Horizon Spinal System Medtronic | NKB |
| Jan 14, 2022 | K201057 | Bio-Medicus Life Support Catheter and Introducer Medtronic, Inc. | QHW |
Newest 50 of 249.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2026 | Medtronic, Inc. CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable Open, Classified |
NVZ | None listed |
| Oct 27, 2026 | Medtronic, Inc. CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable Open, Classified |
NVZ | None listed |
| Oct 27, 2026 | Medtronic, Inc. CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable Open, Classified |
NVZ | None listed |
| Oct 23, 2026 | Medtronic, Inc. 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 scr Open, Classified |
NVY | None listed |
| Apr 24, 2026 | Medtronic, Inc. Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter. Open, Classified |
OAD | None listed |
| Jan 15, 2026 | Medtronic Inc Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090
AB9G12100090
AB9G14080090
AB9G12080090
AB9U12060090
AB9U14100090
AB9U14080090
AB9U12080090
AB9U14060090
AB9G14100090
AB9G12060090 Open, Classified |
QAN | None listed |
| Nov 28, 2025 | Medtronic, Inc. Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4 Open, Classified |
LWS | None listed |
| Jul 23, 2025 | Medtronic, Inc. 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 applica Open, Classified |
NVZ | None listed |
| Jul 23, 2025 | Medtronic, Inc. 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 appli Open, Classified |
NVZ | None listed |
| Jul 17, 2025 | Medtronic, Inc. 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. Open, Classified |
KRG | None listed |
| Jul 17, 2025 | Medtronic, Inc. Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components:
1. Azure Astra application, Software Model Number D00U003;
2. Percept Open, Classified |
KRG | None listed |
| Jun 6, 2025 | Medtronic, Inc. Azure S DR MRI SureScan, Product number W3DR01 Open, Classified |
NVZ | None listed |
| Sep 13, 2024 | Medtronic Inc. 2090 Programmers with serial number prefixes PKK0 and PKK1:
a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM;
b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM;
c) 2 Open, Classified |
NVZ | None listed |
| Jun 26, 2024 | Medtronic Inc. Product not distributed in the US. Implantable Cardioverter Defibrillators:
a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ.
b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1.
c. CLARIA MRI QUAD C Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator Open, Classified |
NIK | None listed |
| Jun 26, 2024 | Medtronic Inc. COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator Open, Classified |
NIK | None listed |
| Jun 26, 2024 | Medtronic Inc. COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator Open, Classified |
NIK | None listed |
| Jun 26, 2024 | Medtronic Inc. Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator Open, Classified |
NIK | None listed |
| Jun 26, 2024 | Medtronic Inc. COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator Open, Classified |
NIK | None listed |
| Jun 26, 2024 | Medtronic Inc. COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator Open, Classified |
NIK | None listed |
| Mar 19, 2024 | Medtronic Inc. Abre Venous Self-expanding Stent System, Product Numbers:
a) AB9U14080090;
b) AB9U18100090;
c) AB9G14100090 Open, Classified |
QAN | None listed |
| Jan 22, 2024 | Medtronic Inc. Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 Open, Classified |
LWS | None listed |
| Jan 2, 2024 | Medtronic Inc. Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile. Completed |
NIP | None listed |
| Dec 9, 2023 | Medtronic Inc. Medtronic SynchroMed, Model A10 Completed |
LKK | None listed |
| Dec 1, 2023 | Medtronic Inc. ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor Open, Classified |
MXD | K200795 K211304 +4 |
| Nov 17, 2023 | Medtronic Inc Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5 Open, Classified |
NTE | K092177 |
| Nov 17, 2023 | Medtronic Inc Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6 Open, Classified |
NTE | K092177 |
| Nov 17, 2023 | Medtronic Inc Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6 Open, Classified |
NTE | K092177 |
| Jul 14, 2022 | Medtronic Inc. EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System Open, Classified |
NIP | None listed |
| Jun 24, 2022 | Medtronic Inc Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip. Open, Classified |
LOX | None listed |
| May 5, 2022 | Medtronic Inc HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System. Open, Classified |
DSQ | None listed |
| Apr 18, 2022 | Medtronic Inc Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System. Open, Classified |
NPV | None listed |
| Apr 14, 2022 | Medtronic Inc HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU Open, Classified |
DSQ | None listed |
| Mar 30, 2022 | Medtronic Inc Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: Open, Classified |
DSQ | None listed |
Newest 50 of 328.