55 results
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42ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Medtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·March 19, 2024
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
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code GDJ·March 19, 2024
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·December 12, 2024
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·August 6, 2025
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 LONG 12GA, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·February 5, 2025
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DTZ·September 12, 2025
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·April 21, 2026
Octopus Evolution AS Tissue Stabilizer, Model TS2500
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code MWS·May 12, 2026
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 Number 12001, d) DLP Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP Pericardial Sump 38.1 cm (15 in), Model Number 12010,
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·March 19, 2024
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 Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 87120; e) DLP Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 80222; f) DLP Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 87122; g) DLP Curved Tip Arterial Cannula 20 Fr., Model Number 87220; h) DLP Curved Tip Arterial Cannula 22 Fr., Model Number 87222; i) DLP" One-Piece Arterial Cannulae, Pediatric 6 Fr, Model Number 77006; j) DLP" One-Piece Pediatric Arterial Cannula 6 Fr, Model Number 77206; k) DLP" One-Piece Pediatric Arterial Cannula 8 Fr, Model Number 77008; l) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77010; m) DLP" One-Piece Pediatric Arterial Cannula 10 Fr, Model Number 77110; n) DLP" One-Piece Pediatric Arterial Cannula 12 Fr, Model Number 77112; o) EOPA" Elongated One Piece Arterial Cannula 20 Fr., Model Number 77420; p) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77422; q) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77522; r) EOPA" Elongated One Piece Arterial Cannula 22 Fr., Model Number 77622; s) EOPA" Elongated One Piece Arterial Cannula 24 Fr., Model Number 77524; t) Select Series" Angled Tip Arterial Cannula 24Fr., Model Number 72424; u) Select Series" Straight Tip Arterial Cannula 20 Fr., Model Number 72120; v) Select Series" Straight Tip Arterial Cannula 24 Fr., Model Number 72224
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·March 19, 2024
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 25010, c) DLP 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003, d) DLP 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000, e) DLP 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G, f) DLP Perfusion/Venting Adapter, Model Number 13002, g) DLP Y Adapter Coronary Perfusion, Model Number 10710
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·March 19, 2024
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code CAC·November 27, 2018
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWA·March 3, 2021
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·December 12, 2024
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·April 21, 2026
Cardioblate CryoFlex Surgical Ablation Console
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code OCL·September 27, 2021
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 Single Stage Venous Cannula, Model Number 68128, d) DLP 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130, e) DLP 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134, f) DLP 12 Fr. Single Stage Venous Cannula, Model Number 67312, g) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67316, h) DLP 16 Fr. Single Stage Venous Cannula, Model Number 67516, i) DLP 18 Fr. Single Stage Venous Cannula, Model Number 66118, j) DLP 18 Fr. Single Stage Venous Cannula, Model Number 67318, k) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67320, l) DLP 20 Fr. Single Stage Venous Cannula, Model Number 69320, m) DLP 20 Fr. Single Stage Venous Cannula, Model Number 67520, n) DLP 22 Fr. Single Stage Venous Cannula, Model Number 66122, o) DLP 22 Fr. Single Stage Venous Cannula, Model Number 67522, p) DLP 24 Fr. Single Stage Venous Cannula, Model Number 67524, q) DLP 26 Fr. Single Stage Venous Cannula, Model Number 67526, r) DLP 28 Fr. Single Stage Venous Cannula, Model Number 66128, s) DLP 28 Fr. Single Stage Venous Cannula, Model Number 39628, t) DLP 28 Fr. Single Stage Venous Cannula, Model Number 67528, u) DLP 30 Fr. Single Stage Venous Cannula, Model Number 66130, v) DLP 31 Fr. Single Stage Venous Cannula, Model Number 69331, w) DLP 32 Fr. Single Stage Venous Cannula, Model Number 66132, x) DLP 34 Fr. Single Stage Venous Cannula, Model Number 67534, y) DLP 36 Fr. Single Stage Venous Cannula, Model Number 66236, z) MC2 28/36 Fr. Two Stage Venous Cannula, Model Number 91228, aa) MC2 29/37 Fr. Two Stage Venous Cannula, Model Number 91229C, bb) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263, cc) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91240C, dd) MC2 32/40 Fr. Two Stage Venous Cannula, Model Number 91263C, ee) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246, ff) MC2 34/46 Fr. Two Stage Venous Cannula, Model Number 91246C, gg) MC2 36/46 Fr. Two Stage Venous Cannula, Model Number 91236C, hh) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251, ii) MC2 36/51 Fr. Two Stage Venous Cannula, Model Number 91251C, jj) VC2" 34/38 Fr. Venous Cannula, Model Number 93438, kk) VC2" 34/48 Fr. Venous Cannula, Model Number 93448C
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·March 19, 2024
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DTZ·December 12, 2022
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·August 6, 2025
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
FDA Recall
Open, Classified
·Medtronic Perfusion Systems·Product code DWF·April 21, 2026