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    IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4.

    FDA Recall
    Terminated ·Medtronic Inc·Product code KRI·December 14, 2009

    Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyrogenic. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DXS·September 9, 2011

    Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded transducer dome (acrylic) with silicone diaphragm on proximal end. Product utilizes a stopcock on proximal and/or distal end. Distal end of tubing features a male luer port. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DXS·September 9, 2011

    Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·February 4, 2016

    Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring pressure between -100 mmHg and +500 mmHg with an accuracy of +/-5 mmHg from -100 mmHg to +300 mmHg and +/-10 mmHg from +301 to +500 mmHg. The Pressure Display Box has an upper and lower alarm setting. The alarm will be activated when the pressure is equal to or beyond the set value. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55431-5604. Product Usage: This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DXS·September 9, 2011

    Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number: CB67532

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·May 9, 2008

    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

    Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·April 29, 2021

    Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·April 29, 2021

    Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·April 29, 2021

    Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·April 29, 2021

    Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DTN·February 4, 2021

    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 Blood Collection Reservoir, 40 micron,Catalog/Model # EL240, Medtronic, Inc., Minneapolis, MN 55432-5804

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DTN·October 1, 2007