Medtronic Perfusion Systems
Parker, CO, US
MEDTRONIC PERFUSION SYSTEMS appears in FDA device records in Parker, CO. FDA records list 29 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 149 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Medtronic Perfusion Systems carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medtronic Cardiovascular Revascularization & Surgical Theraprecall
- Medtronic International Trade Increcall
510(k) clearance history
FDA records hold 29 510(k) clearances for Medtronic Perfusion Systems between 2000 and 2024. The busiest year on record is 2003, with 8. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 2 |
| 2003 | 8 |
| 2004 | 2 |
| 2005 | 6 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2018 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) | DTZ | Substantially Equivalent | |
| K181954 | autoLog IQ Autotransfusion System | CAC | Substantially Equivalent | |
| K123351 | AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE | DTM | Substantially Equivalent | |
| K101186 | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG | DTP | Substantially Equivalent | |
| K090869 | MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD | DWF | Substantially Equivalent | |
| K080824 | BIO-CONSOLE 560 | DWA | Substantially Equivalent | |
| K061254 | EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 | DWF | Substantially Equivalent | |
| K052524 | BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT | DWF | Substantially Equivalent | |
| K052372 | MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C | DWF | Substantially Equivalent | |
| K051303 | BIO-CONSOLE, MODEL 560 | DWA | Substantially Equivalent | |
| K051040 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | JOX | Substantially Equivalent | |
| K050109 | TRILLIUM BIOPUMP PLUS, MODEL BPX80T | KFM | Substantially Equivalent | |
| K043179 | SELECT 3D ARTERIAL CANNULA | DWF | Substantially Equivalent | |
| K041830 | MAGELLAN RATIO DISPENSER KIT | FMF | Substantially Equivalent | |
| K040173 | PEDIATRIC AORTIC ROOT CANNULA | DWF | Substantially Equivalent | |
| K033468 | AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE | DTM | Substantially Equivalent | |
| K033416 | SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE | DWF | Substantially Equivalent | |
| K033264 | MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES | DWF | Substantially Equivalent | |
| K031700 | MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 | DTN | Substantially Equivalent | |
| K031776 | MC2X MULTI-STAGE VENOUS CANNULA | DWF | Substantially Equivalent | |
| K031827 | ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX | DWF | Substantially Equivalent | |
| K031037 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE | DWF | Substantially Equivalent | |
| K030696 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) | DWF | Substantially Equivalent | |
| K021287 | TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT | DTN | Substantially Equivalent | |
| K020147 | MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP | FMF | Substantially Equivalent | |
| K013084 | AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T | DTM | Substantially Equivalent | |
| K012747 | TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) | DPT | Substantially Equivalent | |
| K012743 | TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T | DRY | Substantially Equivalent | |
| K994208 | AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 | DTM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1718389 | 1718389 | MEDTRONIC PERFUSION SYSTEMS | 18501 E Plaza Dr, PARKER, CO 80134 US | 2026 | |
| 2184009 | 1000116158 | MEDTRONIC PERFUSION SYSTEMS | 7611 Northland Dr, Minneapolis, MN 55428 US | 2026 | and 36 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JBPActivated Whole Blood Clotting Time
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- JOXAnalyzer, Heparin, Automated
- CACApparatus, Autotransfusion
- HAMApparatus, Electrosurgical
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording
- DQYCatheter, Percutaneous
- DRACatheter, Steerable
- GDJClamp, Surgical, General & Plastic Surgery
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
- KPEContainer, I.V.
- FMHContainer, Specimen, Sterile
- FLLContinuous Measurement Thermometer
- DWAControl, Pump Speed, Cardiopulmonary Bypass
- DTPDefoamer, Cardiopulmonary Bypass
- KRDDevice, Vascular, For Promoting Embolization
- LDFElectrode, Pacemaker, Temporary
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass
- FZXGuide, Surgical, Instrument
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DWSInstruments, Surgical, Cardiovascular
- FQHLavage, Jet
- PZXLeft Atrial Appendage Clip, Implantable
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- DTZOxygenator, Cardiopulmonary Bypass
- GGYPipette, Diluting
- GGNPlasma, Coagulation Control
- DPTProbe, Blood-Flow, Extravascular
- GFTProtamine Sulphate
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DTNReservoir, Blood, Cardiopulmonary Bypass
- GADRetractor
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- QHWSingle Lumen Ecmo Cannula
- MWSStabilizer, Heart
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass
- OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- FMFSyringe, Piston
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- GKNTimer, Clot, Automated
- DWETubing, Pump, Cardiopulmonary Bypass
Recall records
Showing 25 of 149| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2811-2026 | EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322 | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | Class II | Open, Classified | |
| Z-2810-2026 | EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222 | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | Class II | Open, Classified | |
| Z-2809-2026 | EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722 | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | Class II | Open, Classified | |
| Z-2808-2026 | EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622 | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | Class II | Open, Classified | |
| Z-2807-2026 | EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522 | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | Class II | Open, Classified | |
| Z-2806-2026 | EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422 | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | Class II | Open, Classified | |
| Z-2739-2026 | Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. | Class II | Open, Classified | |
| Z-2738-2026 | Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. | Class II | Open, Classified | |
| Z-2577-2026 | Octopus 4 Tissue Stabilizer, Model 29400 | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. | Class II | Open, Classified | |
| Z-2576-2026 | Octopus Evolution AS Tissue Stabilizer, Model TS2500 | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. | Class II | Open, Classified | |
| Z-2575-2026 | Octopus Evolution Tissue Stabilizer, Model TS2000 | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. | Class II | Open, Classified | |
| Z-2222-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter | Certain lots of product have the potential for a sterile barrier breach. | Class II | Open, Classified | |
| Z-2221-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter | Certain lots of product have the potential for a sterile barrier breach. | Class II | Open, Classified | |
| Z-2220-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter | Certain lots of product have the potential for a sterile barrier breach. | Class II | Open, Classified | |
| Z-2219-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter | Certain lots of product have the potential for a sterile barrier breach. | Class II | Open, Classified | |
| Z-2218-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter | Certain lots of product have the potential for a sterile barrier breach. | Class II | Open, Classified | |
| Z-2217-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter | Certain lots of product have the potential for a sterile barrier breach. | Class II | Open, Classified | |
| Z-2216-2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter | Certain lots of product have the potential for a sterile barrier breach. | Class II | Open, Classified | |
| Z-2215-2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter | Certain lots of product have the potential for a sterile barrier breach. | Class II | Open, Classified | |
| Z-2214-2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter | Certain lots of product have the potential for a sterile barrier breach. | Class II | Open, Classified | |
| Z-1473-2026 | Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 | During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. | Class II | Open, Classified | |
| Z-0539-2026 | Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 | Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges. | Class II | Open, Classified | |
| Z-0509-2026 | MC3 VitalFlow Console, REF 58100; Blood pump of ecmo | As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout. | Class II | Open, Classified | |
| Z-0487-2026 | Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B | Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements. | Class II | Open, Classified | |
| Z-2482-2025 | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115 | The catheters may not retain their shape. | Class I | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain