Cardiology FDA Alerts
Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK 15 Monitor/Defibrillator
Call 1 Recall: Endologix, Inc. Recalls AFX Endovascular AAA Systems Due to Risk of Type III Endoleaks
Class 1 Recall: Medtronic HeartWare HVAD System Recalled Due to Unintended Intermittent Electrical Disconnection between The Power Source and The Controller
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 Recalls MindFrame Capture LP Revascularization Device Due to Wire Material That May Break or Separate During Use
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 Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators Due to Manufacturing Error Preventing Electrical Shock Delivery
Class 1 Recall: Edwards Lifesciences LLC. Recalls Certitude Delivery System Due to Mold Overflow Defect Which May Obstruct Blood Flow
Class 1 Recall: Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to Risk of Valve Failure Preventing Balloon Inflation and Deflation
Class 1 Recall: Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator Due to an Electrical Issue Which May Cause the Device to Shut Down Unexpectedly