Company ยท US
Medtronic Perfusion Systems
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2024. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
141recalls (23 in 12 months)
132recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 89 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 16 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 15 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 6 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 5 |
| DXS | Gauge, Pressure, Coronary, Cardiopulmonary Bypass | 5 |
| MWS | Stabilizer, Heart | 4 |
| CAC | Apparatus, Autotransfusion | 3 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 3 |
| DRA | Catheter, Steerable | 2 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 2 |
| FMF | Syringe, Piston | 2 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | 2 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | 2 |
| DPT | Probe, Blood-Flow, Extravascular | 1 |
| DQY | Catheter, Percutaneous | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 |
| DTP | Defoamer, Cardiopulmonary Bypass | 1 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 1 |
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2024 | K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator wi Medtronic Perfusion Systems | DTZ |
| Aug 22, 2018 | K181954 | autoLog IQ Autotransfusion System Medtronic Perfusion Systems | CAC |
| Mar 19, 2013 | K123351 | AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE Medtronic Perfusion Systems | DTM |
| Sep 3, 2010 | K101186 | AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG Medtronic Perfusion Systems | DTP |
| Aug 27, 2009 | K090869 | MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD Medtronic Perfusion Systems | DWF |
| May 7, 2008 | K080824 | BIO-CONSOLE 560 Medtronic Perfusion Systems | DWA |
| Jun 23, 2006 | K061254 | EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 Medtronic Perfusion Systems | DWF |
| Nov 22, 2005 | K052524 | BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT Medtronic Perfusion Systems | DWF |
| Sep 22, 2005 | K052372 | MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C Medtronic Perfusion Systems | DWF |
| Jun 10, 2005 | K051303 | BIO-CONSOLE, MODEL 560 Medtronic Perfusion Systems | DWA |
| May 24, 2005 | K051040 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR Medtronic Perfusion Systems | JOX |
| Feb 11, 2005 | K050109 | TRILLIUM BIOPUMP PLUS, MODEL BPX80T Medtronic Perfusion Systems | KFM |
| Feb 8, 2005 | K043179 | SELECT 3D ARTERIAL CANNULA Medtronic Perfusion Systems | DWF |
| Sep 29, 2004 | K041830 | MAGELLAN RATIO DISPENSER KIT Medtronic Perfusion Systems | FMF |
| Mar 19, 2004 | K040173 | PEDIATRIC AORTIC ROOT CANNULA Medtronic Perfusion Systems | DWF |
| Nov 14, 2003 | K033468 | AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE Medtronic Perfusion Systems | DTM |
| Nov 5, 2003 | K033416 | SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE Medtronic Perfusion Systems | DWF |
| Oct 31, 2003 | K033264 | MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES Medtronic Perfusion Systems | DWF |
| Aug 29, 2003 | K031700 | MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 Medtronic Perfusion Systems | DTN |
| Jul 25, 2003 | K031776 | MC2X MULTI-STAGE VENOUS CANNULA Medtronic Perfusion Systems | DWF |
| Jul 2, 2003 | K031827 | ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX Medtronic Perfusion Systems | DWF |
| May 13, 2003 | K031037 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE Medtronic Perfusion Systems | DWF |
| Apr 11, 2003 | K030696 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) Medtronic Perfusion Systems | DWF |
| May 7, 2002 | K021287 | TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT Medtronic Perfusion Systems | DTN |
| Apr 3, 2002 | K020147 | MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP Medtronic Perfusion Systems | FMF |
| Sep 27, 2001 | K013084 | AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T Medtronic Perfusion Systems | DTM |
| Sep 14, 2001 | K012747 | TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) Medtronic Perfusion Systems | DPT |
| Sep 14, 2001 | K012743 | TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T Medtronic Perfusion Systems | DRY |
| Jan 13, 2000 | K994208 | AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 Medtronic Perfusion Systems | DTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322 Open, Classified |
DWF | K260195 |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222 Open, Classified |
DWF | K260195 |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722 Open, Classified |
DWF | K031037 |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622 Open, Classified |
DWF | K031037 |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522 Open, Classified |
DWF | K031037 |
| Jul 27, 2026 | Medtronic Perfusion Systems EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422 Open, Classified |
DWF | K031037 |
| Jul 15, 2026 | Medtronic Perfusion Systems Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula Open, Classified |
DWF | K153598 |
| Jul 15, 2026 | Medtronic Perfusion Systems Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula Open, Classified |
DWF | K024069 K180456 |
| Jun 24, 2026 | Medtronic Perfusion Systems Octopus 4 Tissue Stabilizer, Model 29400 Open, Classified |
MWS | None listed |
| Jun 24, 2026 | Medtronic Perfusion Systems Octopus Evolution AS Tissue Stabilizer, Model TS2500 Open, Classified |
MWS | None listed |
| Jun 24, 2026 | Medtronic Perfusion Systems Octopus Evolution Tissue Stabilizer, Model TS2000 Open, Classified |
MWS | None listed |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 |
| May 20, 2026 | Medtronic Perfusion Systems Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter Open, Classified |
DWF | K860149 K953945 |
| Feb 26, 2026 | Medtronic Perfusion Systems Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 Open, Classified |
MWS | None listed |
| Nov 18, 2025 | Medtronic Perfusion Systems Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 Open, Classified |
JBP | K860122 |
| Nov 14, 2025 | Medtronic Perfusion Systems MC3 VitalFlow Console, REF 58100; Blood pump of ecmo Open, Classified |
QNR | K230364 K250199 |
| Nov 10, 2025 | Medtronic Perfusion Systems Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B Open, Classified |
DTZ | K241352 |
| Sep 3, 2025 | Medtronic Perfusion Systems DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115 Open, Classified |
DWF | K834039 |
| Sep 3, 2025 | Medtronic Perfusion Systems DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110 Open, Classified |
DWF | K834039 |
| Sep 3, 2025 | Medtronic Perfusion Systems DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113 Open, Classified |
DWF | K834039 |
| Mar 13, 2025 | Medtronic Perfusion Systems Aortic Root Cannula:
1. DLP Aortic Root Cannula
A. CANNULA 11012 AR FLOWGUARD 12GA, model no
11012
B. CANNULA 11014 AR FLOWGUARD 14GA, model no.
11014
2. MiAR Cannula:
A. CANNULA 11012L AR FLOWGUARD Open, Classified |
DWF | K100274 |
| Jan 17, 2025 | Medtronic Perfusion Systems Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr) Open, Classified |
DWF | K840002 |
| Jan 17, 2025 | Medtronic Perfusion Systems EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) Open, Classified |
DWF | K031037 |
| Jan 17, 2025 | Medtronic Perfusion Systems DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr) Open, Classified |
DWF | K024069 |
| Nov 4, 2024 | Medtronic Perfusion Systems Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery Open, Classified |
DWF | K790565 |
| Sep 12, 2024 | Medtronic Perfusion Systems Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 Open, Classified |
DWF | K120988 |
| Jul 23, 2024 | Medtronic Perfusion Systems TourniKwik Tourniquet Set (CFN 79012) Open, Classified |
GDJ | K855144 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Venous Cannulae:
a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120,
b) DLP 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124,
c) DLP 28 Fr. Malleable Open, Classified |
DWF | K022272 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Suction Tubes:
a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050,
b) DLP Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10052,
c) DLP Suction Tube 6-Fr Open, Classified |
DTS | None listed |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Intracoronary Shunts:
a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 31100;
b) ClearView 1.25 mm Intracoronary Shunt, Model Numbers: 31125;
c) ClearView 2.00 mm Intracoronary Open, Classified |
DWF | K120612 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Disposable Pressure Display Sets:
a) DLP 114.3 cm (45 in), Model Number 61000;
b) DLP 114.3 cm (45 in), Model Number 62000 Open, Classified |
DXS | K113235 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Cardioplegia Adapters:
a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,
b) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 250 Open, Classified |
DWF | K182586 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Aortic Root Cannulae and Cardioplegia Needles:
a) DLP 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009;
b) DLP 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length Open, Classified |
DWF | K182586 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Vessel Cannulae:
a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004;
b) DLP 3 mm Vessel Cannula Blunt Tip, Model Number 30003 Open, Classified |
DWF | K810820 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Tourniquet Sets:
a) DLP 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004,
b) DLP 7 in (17.8 cm) Tourniquet Kit, Model Number 79009 Open, Classified |
GDJ | None listed |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Left Heart Vent Catheters:
a) DLP Intracardiac Sump 20 Fr, Model Number 12012,
b) DLP Left Heart Vent Catheter 10 Fr., Model Number 12008,
c) DLP Left Heart Vent Catheter 13 Fr., Model N Open, Classified |
DWF | K850385 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001 Open, Classified |
DWF | K810820 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 Open, Classified |
DWF | K131269 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Clearview Blower/Mister, Model Number 22120 Open, Classified |
FQH | K973485 |
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Arterial Cannulae packaged as:
a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020;
b) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220;
c) DLP Curved Met Open, Classified |
DWF | K840002 |
| Mar 19, 2024 | Medtronic Perfusion Systems Medtronic DLP Vessel Cannula, Model Number REF 30000 Open, Classified |
DWF | K810820 |
| Jan 27, 2023 | Medtronic Perfusion Systems Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass. Open, Classified |
DTZ | K203111 |
| Jan 27, 2023 | Medtronic Perfusion Systems Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass. Open, Classified |
DTZ | K203111 |
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