FDA Alerts

Class 1 Recall: Maquet Datascope Corp./Getinge Group Recalls the CARDIOSAVE Hybrid Intra-aortic Balloon Pump due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy

Class 1 Recall: Medtronic HeartWare HVAD System Recalled Due to Unintended Intermittent Electrical Disconnection between The Power Source and The Controller

Class 1 Recall: Abbott Recalls the HeartMate 3 Left Ventricular Assist System Due to Potential Malfunction that may Lead to Graft Occlusion

Class 1 Recall: Medtronic Recalls MindFrame Capture LP Revascularization Device Due to Wire Material That May Break or Separate During Use

Class 1 Recall: Vyaire Medical Recalls AirLife Resuscitation Devices and Broselow Convenience Kits Due to Risk of Malfunction Caused by Error in Product Design

Class 1 Recall: Fabius Anesthesia Machines by Dräger Medical

Class 2 Recall: Terumo Recalls Sarns" TCM and TCM II Cooling and Heating Systems and HX2" Temperature Management Systems Due to Revised Cleaning Instructions

Class 1 Recall: Becton Dickinson (BD) and Company Recalls Vacutainer® EDTA Blood Collection Tubes Due to Chemical Interference with Certain Tests

Class 1 Recall: Monteris Medical NeuroBlate System Recalled Due to Unexpected Heating of Laser Delivery Probes

Class 1 Recall: Medtronic Recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery