Panels › Cardiovascular
Cardiovascular devices
304 product codes reviewed by the Cardiovascular panel. 19,244 510(k) clearances and 6,943 recalls in the FDA data, 81% of those recalls name a 510(k).
415510(k)s in 12 months
469recalls in 12 months
5,607recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 620 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 563 | 20 |
| DYB | Introducer, Catheter | 389 | 27 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 338 | 4 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 294 | 36 |
| DQO | Catheter, Intravascular, Diagnostic | 285 | 26 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 267 | 1 |
| DQX | Wire, Guide, Catheter | 258 | 7 |
| DRS | Transducer, Blood-Pressure, Extravascular | 236 | 2 |
| OEZ | Cardiovascular Procedure Kit | 232 | 50 |
| DSP | System, Balloon, Intra-Aortic And Control | 194 | 7 |
| KRA | Catheter, Continuous Flush | 137 | 41 |
| DQA | Oximeter | 128 | 9 |
| DQK | Computer, Diagnostic, Programmable | 125 | 2 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 121 | 0 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 15 | 36 |
| OEZ | Cardiovascular Procedure Kit | 2 | 0 | 50 |
| DYB | Introducer, Catheter | 2 | 19 | 27 |
| KRA | Catheter, Continuous Flush | 2 | 5 | 41 |
| NLH | Catheter, Recording, Electrode, Reprocessed | 2 | 1 | 32 |
| OES | Cardiac Catheterization Kit | 2 | 0 | 33 |
| DQK | Computer, Diagnostic, Programmable | 2 | 29 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 31 | 0 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 10 | 20 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 3 | 26 |
| QJP | Catheter, Percutaneous, Neurovasculature | 2 | 23 | 0 |
| DQA | Oximeter | 2 | 13 | 9 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 1 | 20 |
| DQX | Wire, Guide, Catheter | 2 | 12 | 7 |
| OEQ | Angiography/Angioplasty Kit | 2 | 0 | 19 |
| OFF | Central Venous Catheter Tray | 2 | 0 | 19 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | 6 | 11 |
| NRY | Catheter, Thrombus Retriever | 2 | 14 | 2 |
| DQY | Catheter, Percutaneous | 2 | 13 | 2 |
| DXT | Injector And Syringe, Angiographic | 2 | 7 | 8 |
| MOF | Guide, Wire, Catheter, Neurovasculature | 2 | 12 | 0 |
| OFG | Ct Biopsy Tray | 2 | 0 | 12 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 2 | 12 | 0 |
| DPS | Electrocardiograph | 2 | 7 | 4 |
| DWJ | System, Thermal Regulating | 2 | 6 | 3 |
| JOW | Sleeve, Limb, Compressible | 2 | 9 | 0 |
| KRD | Device, Vascular, For Promoting Embolization | 2 | 8 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 2 | 5 | 3 |
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | 2 | 3 | 5 |
| QEZ | Aspiration Thrombectomy Catheter | 2 | 8 | 0 |
| DQD | Stethoscope, Electronic | 2 | 7 | 0 |
| DSP | System, Balloon, Intra-Aortic And Control | 2 | 0 | 7 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | 5 | 2 |
| DXC | Clamp, Vascular | 2 | 6 | 0 |
| DXQ | Blood Pressure Cuff | 2 | 5 | 1 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 2 | 6 | 0 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 2 | 1 | 5 |
| DPW | Flowmeter, Blood, Cardiovascular | 2 | 4 | 1 |
| DRA | Catheter, Steerable | 2 | 1 | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 5 | 0 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 | 0 | 5 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 2 | 5 | 0 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | 4 | 1 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 2 | 5 | 0 |
| OBJ | Catheter, Ultrasound, Intravascular | 2 | 4 | 1 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 3 | 0 | 4 |
| MWS | Stabilizer, Heart | 1 | 0 | 4 |
| QME | Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate | 2 | 4 | 0 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 2 | 2 | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | 2 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 2 | 1 | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 2 | 3 | 0 |
| DSH | Recorder, Magnetic Tape, Medical | 2 | 3 | 0 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 2 | 1 | 2 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 2 | 1 | 2 |
| DXF | Catheter, Septostomy | 2 | 3 | 0 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | 0 | 3 |
| OFC | Catheter Introducer Kit | 2 | 0 | 3 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | 2 | 3 | 0 |
| PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | 3 | 0 | 3 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 2 | 2 | 0 |
| DSB | Plethysmograph, Impedance | 2 | 2 | 0 |
| DXE | Catheter, Embolectomy | 2 | 0 | 2 |
| DYG | Catheter, Flow Directed | 2 | 0 | 2 |
| IZQ | Injector, Contrast Medium, Automatic | 2 | 2 | 0 |
| KRH | Ring, Annuloplasty | 2 | 2 | 0 |
| LDF | Electrode, Pacemaker, Temporary | 2 | 1 | 1 |
| MGZ | Valvulotome | 2 | 1 | 1 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | 2 | 2 | 0 |
| MUD | Oximeter, Tissue Saturation | 2 | 1 | 1 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 2 | 0 | 2 |
| OBH | Monitor, Extracellular Fluid, Lymphedema, Extremity | 2 | 2 | 0 |
| OFB | Catheter Guide Wire Kit | 2 | 0 | 2 |
| OFK | Percutaneous Atrial Catheter Kit | 2 | 0 | 2 |
| OFL | Percutaneous Sheath Introducer Kit | 2 | 0 | 2 |
| OZT | Balloon Aortic Valvuloplasty | 2 | 2 | 0 |
| PNE | Reprocessed Catheter Introducer | 2 | 2 | 0 |
| PPN | Percutaneous Catheter, Ultrasound | 2 | 2 | 0 |
| PPW | Adjunctive Cardiovascular Status Indicator | 2 | 2 | 0 |
| QEY | Mechanical Thrombolysis Catheter | 2 | 2 | 0 |
| QNR | Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | 2 | 0 | 2 |
| SAT | Pulmonary Hypertension Machine Learning-Based Notification Software | 2 | 2 | 0 |
| DRM | Compressor, Cardiac, External | 2 | 0 | 1 |
| DRN | Device, Counter-Pulsating, External | 2 | 1 | 0 |
| DTK | Filter, Intravascular, Cardiovascular | 2 | 0 | 1 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 | 1 | 0 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 2 | 1 | 0 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | 0 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | 1 | 0 |
| DXJ | Display, Cathode-Ray Tube, Medical | 2 | 1 | 0 |
| DXO | Transducer, Pressure, Catheter Tip | 2 | 1 | 0 |
| DXX | System, Catheter Control, Steerable | 2 | 1 | 0 |
| MAV | Syringe, Balloon Inflation | 2 | 1 | 0 |
| MCW | Catheter, Peripheral, Atherectomy | 2 | 1 | 0 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 2 | 1 | 0 |
| NMK | Trocar, Reprocessed | 2 | 1 | 0 |
| OFD | Catheter Introducer Kit | 2 | 0 | 1 |
| OFM | Phlebotomy Blood Collection Kit | 2 | 0 | 1 |
| PAW | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement | 2 | 1 | 0 |
| PDU | Catheter For Crossing Total Occlusions | 2 | 1 | 0 |
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Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2026 | Cardinal Health 200, LLC Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT, CABG, , CATALOG # PCOCCG3A12;
2) KIT, CABG, Open, Classified |
OEZ | None listed |
| Nov 2, 2026 | Cardinal Health 200, LLC Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: KIT, CATH LAB ADMIT, CATALOG # ADMMH2133A. Open, Classified |
OES | None listed |
| Nov 2, 2026 | Cardinal Health 200, LLC Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVU3;
2) CATH A Open, Classified |
OEQ | None listed |
| Oct 30, 2026 | Artivion, Inc CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010 Open, Classified |
DXZ | K101866 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130;
Material Number: M001195940 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130;
Material Number: M001195910 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155;
Material Number: M001195850 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130;
Material Number: M001195840 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130;
Material Number: M001195810 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155;
Material Number: M001195750 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130;
Material Number: M001195740 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155;
Material Number: M001195720 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130;
Material Number: M001195710 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130;
Material Number: M001195670 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130;
Material Number: M001195660 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155;
Material Number: M001195650 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130;
Material Number: M001195640 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155;
Material Number: M001195620 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130;
Material Number: M001195610 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155;
Material Number: M001195510 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130;
Material Number: M001195500 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155;
Material Number: M001195480 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130;
Material Number: M001195470 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155;
Material Number: M001195450 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130;
Material Number: M001195440 Open, Classified |
KRA | K163701 |
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