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Medtronic Perfusion Systems

101 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonar recall (Z-2806-2026)Medtronic Perfusion Systems2026-07-27
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonar recall (Z-2807-2026)Medtronic Perfusion Systems2026-07-27
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmon recall (Z-2808-2026)Medtronic Perfusion Systems2026-07-27
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmon recall (Z-2809-2026)Medtronic Perfusion Systems2026-07-27
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an recall (Z-2810-2026)Medtronic Perfusion Systems2026-07-27
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial recall (Z-2811-2026)Medtronic Perfusion Systems2026-07-27
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmon recall (Z-2738-2026)Medtronic Perfusion Systems2026-07-15
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary byp recall (Z-2739-2026)Medtronic Perfusion Systems2026-07-15
Octopus Evolution Tissue Stabilizer, Model TS2000 recall (Z-2575-2026)Medtronic Perfusion Systems2026-06-24
Octopus Evolution AS Tissue Stabilizer, Model TS2500 recall (Z-2576-2026)Medtronic Perfusion Systems2026-06-24
Octopus 4 Tissue Stabilizer, Model 29400 recall (Z-2577-2026)Medtronic Perfusion Systems2026-06-24
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardi recall (Z-2214-2026)Medtronic Perfusion Systems2026-05-20
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardi recall (Z-2215-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopu recall (Z-2216-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopul recall (Z-2217-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopul recall (Z-2218-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopul recall (Z-2219-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopu recall (Z-2220-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopul recall (Z-2221-2026)Medtronic Perfusion Systems2026-05-20
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopul recall (Z-2222-2026)Medtronic Perfusion Systems2026-05-20
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSM recall (Z-1473-2026)Medtronic Perfusion Systems2026-02-26
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 recall (Z-0539-2026)Medtronic Perfusion Systems2025-11-18
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo recall (Z-0509-2026)Medtronic Perfusion Systems2025-11-14
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous recall (Z-0487-2026)Medtronic Perfusion Systems2025-11-10
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13 recall (Z-2480-2025)Medtronic Perfusion Systems2025-09-03
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10 recall (Z-2481-2025)Medtronic Perfusion Systems2025-09-03
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15 recall (Z-2482-2025)Medtronic Perfusion Systems2025-09-03
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model recall (Z-1306-2025)Medtronic Perfusion Systems2025-03-13
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr) recall (Z-0984-2025)Medtronic Perfusion Systems2025-01-17
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) recall (Z-0985-2025)Medtronic Perfusion Systems2025-01-17
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr) recall (Z-0986-2025)Medtronic Perfusion Systems2025-01-17
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary b recall (Z-0289-2025)Medtronic Perfusion Systems2024-11-04
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 recall (Z-3128-2024)Medtronic Perfusion Systems2024-09-12
TourniKwik Tourniquet Set (CFN 79012) recall (Z-2423-2024)Medtronic Perfusion Systems2024-07-23
Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., recall (Z-1793-2024)Medtronic Perfusion Systems2024-05-10
Medtronic Clearview Blower/Mister, Model Number 22120 recall (Z-1794-2024)Medtronic Perfusion Systems2024-05-10
Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 recall (Z-1795-2024)Medtronic Perfusion Systems2024-05-10
Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001 recall (Z-1796-2024)Medtronic Perfusion Systems2024-05-10
Medtronic Left Heart Vent Catheters: a) DLP Intracardiac Sump 20 Fr, Model Number 12012, b recall (Z-1797-2024)Medtronic Perfusion Systems2024-05-10
Medtronic Tourniquet Sets: a) DLP 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) recall (Z-1798-2024)Medtronic Perfusion Systems2024-05-10
Medtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DL recall (Z-1799-2024)Medtronic Perfusion Systems2024-05-10
Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr) Aortic Root C recall (Z-1800-2024)Medtronic Perfusion Systems2024-05-10
Medtronic Cardioplegia Adapters: a) DLP 1.8 m (6 ft) Pressure Monitoring Extension Line Ad recall (Z-1801-2024)Medtronic Perfusion Systems2024-05-10
Medtronic Disposable Pressure Display Sets: a) DLP 114.3 cm (45 in), Model Number 61000; b recall (Z-1802-2024)Medtronic Perfusion Systems2024-05-10
Medtronic Intracoronary Shunts: a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 3 recall (Z-1803-2024)Medtronic Perfusion Systems2024-05-10
Medtronic Suction Tubes: a) DLP Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 1 recall (Z-1804-2024)Medtronic Perfusion Systems2024-05-10
Medtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Numb recall (Z-1805-2024)Medtronic Perfusion Systems2024-05-10
Medtronic DLP Vessel Cannula, Model Number REF 30000 recall (Z-1316-2024)Medtronic Perfusion Systems2024-03-19
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom recall (Z-1023-2023)Medtronic Perfusion Systems2023-01-27
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR recall (Z-1024-2023)Medtronic Perfusion Systems2023-01-27
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom recall (Z-1025-2023)Medtronic Perfusion Systems2023-01-27
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom recall (Z-1026-2023)Medtronic Perfusion Systems2023-01-27
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated A recall (Z-1027-2023)Medtronic Perfusion Systems2023-01-27
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated A recall (Z-1028-2023)Medtronic Perfusion Systems2023-01-27
Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Bala recall (Z-1190-2021)Medtronic Perfusion Systems2021-03-17
Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir wit recall (Z-1191-2021)Medtronic Perfusion Systems2021-03-17
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardioto recall (Z-1192-2021)Medtronic Perfusion Systems2021-03-17
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B recall (Z-1193-2021)Medtronic Perfusion Systems2021-03-17
Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity P recall (Z-1194-2021)Medtronic Perfusion Systems2021-03-17
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie recall (Z-1195-2021)Medtronic Perfusion Systems2021-03-17
Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous recall (Z-1196-2021)Medtronic Perfusion Systems2021-03-17
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Aff recall (Z-1197-2021)Medtronic Perfusion Systems2021-03-17
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity recall (Z-1198-2021)Medtronic Perfusion Systems2021-03-17
Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Ve recall (Z-1199-2021)Medtronic Perfusion Systems2021-03-17
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during recall (Z-0535-2018)Medtronic Perfusion Systems2018-01-30
DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopul recall (Z-2764-2017)Medtronic Perfusion Systems2017-07-10
DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in eithe recall (Z-2765-2017)Medtronic Perfusion Systems2017-07-10
DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring need recall (Z-2766-2017)Medtronic Perfusion Systems2017-07-10
DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reac recall (Z-2767-2017)Medtronic Perfusion Systems2017-07-10
DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach recall (Z-2768-2017)Medtronic Perfusion Systems2017-07-10
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Ter recall (Z-1023-2016)Medtronic Perfusion Systems2016-02-26
MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the recall (Z-2735-2015)Medtronic Perfusion Systems2015-09-04
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U recall (Z-2736-2015)Medtronic Perfusion Systems2015-09-04
Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygen recall (Z-2420-2015)Medtronic Perfusion Systems2015-08-19
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Ca recall (Z-1914-2015)Medtronic Perfusion Systems2015-06-26
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surfa recall (Z-0531-2015)Medtronic Perfusion Systems2014-12-16
Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measur recall (Z-0077-2012)Medtronic Perfusion Systems2011-10-20
Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized b recall (Z-0078-2012)Medtronic Perfusion Systems2011-10-20
Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The f recall (Z-0079-2012)Medtronic Perfusion Systems2011-10-20
Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilize recall (Z-0134-2011)Medtronic Perfusion Systems2010-11-01
Medtronic AFFINITY NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with recall (Z-1919-2008)Medtronic Perfusion Systems2008-07-24
Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass Oxygenato recall (Z-1920-2008)Medtronic Perfusion Systems2008-07-24
Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for Cardiopulmonary Byp recall (Z-1921-2008)Medtronic Perfusion Systems2008-07-24
Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda Bio recall (Z-1922-2008)Medtronic Perfusion Systems2008-07-24
Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog recall (Z-1923-2008)Medtronic Perfusion Systems2008-07-24
Medtronic Malleable Single Stage Venous Cannula with Carmeda BioActive Surface, for Vascul recall (Z-1924-2008)Medtronic Perfusion Systems2008-07-24
Medtronic Arterial Cannula Straight Beveled tip, for Cardiopulmonary Bypass. Catalog Numbe recall (Z-1925-2008)Medtronic Perfusion Systems2008-07-24
Medtronic Select 3D and Select CAP Aterial Cannulae with flexible, thin wall wire-wound PV recall (Z-1926-2008)Medtronic Perfusion Systems2008-07-24
Medtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog Numbers recall (Z-1927-2008)Medtronic Perfusion Systems2008-07-24
Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog Numb recall (Z-1928-2008)Medtronic Perfusion Systems2008-07-24
Medtronic Bio-Medicus Percutaneous Cannula & Introducer Set, Catalog Number: CB96535-015 recall (Z-1929-2008)Medtronic Perfusion Systems2008-07-24
Medtronic Catheter, Cannula and Tubing, for Vascular Cardiopulmonary Bypass. This product recall (Z-1930-2008)Medtronic Perfusion Systems2008-07-24
Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant recall (Z-0476-2008)Medtronic Perfusion Systems2008-01-26
Medtronic Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Mi recall (Z-0477-2008)Medtronic Perfusion Systems2008-01-26
Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use recall (Z-1227-2007)Medtronic Perfusion Systems2007-09-25
Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Man recall (Z-1110-2007)Medtronic Perfusion Systems2007-07-26
Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB S recall (Z-1090-2007)Medtronic Perfusion Systems2007-07-23
Medtronic 2T10R1 Intersept Custom Tubing Pack. Pack 2T10R1 consists of two PVC lines; one recall (Z-0583-2007)Medtronic Perfusion Systems2007-03-08
Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this pr recall (Z-0340-2007)Medtronic Perfusion Systems2007-01-25
Medtronic Custom Packs and Total System Packs. Pack can contain a number of different comp recall (Z-0808-05)Medtronic Perfusion Systems2005-05-10
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