Thoratec Corp. - HeartMate III Left Ventricular Assist System - Class 1 Recall
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3TM Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3TM Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3TM LVAS Implant Kit, US 6. HeartMate 3TM LVAS Implant Kit, OUS HeartMate 3"Left Ventricular Assist System: The HeartMate 3 LVAS is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVA...
Source: Medical Device Recalls - March 23, 2024 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - DLP Vessel Cannula - Class 2 Recall
Medtronic DLP Vessel Cannula, Model Number REF 30000 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 20, 2024 Category: Medical Devices Source Type: alerts
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - 2D Perfusion - Class 2 Recall
2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 21, 2023 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Affinity Fusion Oxygenator - Class 2 Recall
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2023 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Affinity Fusion Oxygenator - Class 2 Recall
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2023 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Affinity Fusion Oxygenator - Class 2 Recall
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2023 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Affinity Fusion Oxygenator - Class 2 Recall
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2023 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Affinity Fusion Oxygenator - Class 2 Recall
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2023 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Affinity Fusion Oxygenator - Class 2 Recall
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 28, 2023 Category: Medical Devices Source Type: alerts
XVIVO PERFUSION AB - XPS With Steen Solution Perfusate - Class 2 Recall
XVIVO Organ Chamber REF 19020 (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 2, 2022 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - CardioblateGemini - Class 2 Recall
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 26, 2022 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Medtronic Perfusion Tubing Packs - Class 2 Recall
Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5. CUSTOM PACK BB7H99R22 NEONAT (Model BB7H99R22); 6. CUSTOM PACK BB7P46R4 316-14 (Model BB7P46R4); 7. CUSTOM PACK BB7P48R4 14-38 (Model BB7P48R4); 8. CUSTOM PACK BB7W03R8 CCSM NEON (Model BB7W03R8); 9. CUSTOM PACK BB7W80R7 BASC PEDS (Model BB7W80R7); 10. CUSTOM PACK BB8B09R7 INFANT (Model BB8B09R...
Source: Medical Device Recalls - January 13, 2022 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Cardioblate CryoFlex - Class 2 Recall
Cardioblate CryoFlex Surgical Ablation Console (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 20, 2021 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - BioMedicus Insertion Kits - Class 2 Recall
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 2, 2021 Category: Medical Devices Source Type: alerts
Medtronic Perfusion Systems - Class 2 Recall
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 23, 2021 Category: Medical Devices Source Type: alerts
