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Medtronic Perfusion Systems

FDA Regulatory Profile

Summary

Total Recalls
105 (15 Class I)
510(k) Clearances
29
Inspections
11
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2217-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; CardiopulmonaryApril 21, 2026
Z-2221-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; CardiopulmonaryApril 21, 2026
Z-2216-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; CardiopulmonarApril 21, 2026
Z-2222-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; CardiopulmonaryApril 21, 2026
Z-2220-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; CardiopulmonarApril 21, 2026
Z-2219-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; CardiopulmonaryApril 21, 2026
Z-2214-2026Class IIMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; CardiopulmoApril 21, 2026
Z-2215-2026Class IIMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; CardiopulmonaApril 21, 2026
Z-2218-2026Class IIMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; CardiopulmonaryApril 21, 2026
Z-1473-2026Class IIOctopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1January 13, 2026
Z-0539-2026Class IIMedtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03October 20, 2025
Z-0509-2026Class IIMC3 VitalFlow Console, REF 58100; Blood pump of ecmoOctober 3, 2025
Z-0487-2026Class IIAffinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir,September 12, 2025
Z-2480-2025Class IDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model August 6, 2025
Z-2481-2025Class IDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model August 6, 2025
Z-2482-2025Class IDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model August 6, 2025
Z-1306-2025Class IAortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 1101February 5, 2025
Z-0985-2025Class IIEOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)December 12, 2024
Z-0984-2025Class IIDLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)December 12, 2024
Z-0986-2025Class IISelect Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)December 12, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity July 10, 2024
K181954autoLog IQ Autotransfusion SystemAugust 22, 2018
K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEMarch 19, 2013
K101186AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAGSeptember 3, 2010
K090869MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TAugust 27, 2009
K080824BIO-CONSOLE 560May 7, 2008
K061254EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222June 23, 2006
K052524BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KITNovember 22, 2005
K052372MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437CSeptember 22, 2005
K051303BIO-CONSOLE, MODEL 560June 10, 2005
K051040HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 PORMay 24, 2005
K050109TRILLIUM BIOPUMP PLUS, MODEL BPX80TFebruary 11, 2005
K043179SELECT 3D ARTERIAL CANNULAFebruary 8, 2005
K041830MAGELLAN RATIO DISPENSER KITSeptember 29, 2004
K040173PEDIATRIC AORTIC ROOT CANNULAMarch 19, 2004
K033468AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACENovember 14, 2003
K033416SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMENovember 5, 2003
K033264MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIESOctober 31, 2003
K031700MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711August 29, 2003
K031776MC2X MULTI-STAGE VENOUS CANNULAJuly 25, 2003