Medical Devices

2017 Medical Device Recalls

The list below contains recalls that were issued in 2017.

2017 Recalls

Device NameDate
Physio-Control Inc. Recalls Defibrillation Electrodes Due to Incorrect Placement Instructions for Infants Depicted on Artwork 12/19/17
OriGen Biomedical Medical Recalls Reinforced Dual Lumen ECMO Catheter Due to Separation 10/25/17
St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion - Update 10/19/17
Spectranetics Corp. Recalls Bridge Occlusion Balloon Catheter Due to Risk of Blocked Guidewire Lumen Preventing Balloon Utilization 09/25/17
Leonhard Lang Multi-function Defibrillation Electrodes Will Not Work with ZOLL AED Plus 09/13/17
Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump 09/06/17
Cook Medical Inc. Recalls Zenith Alpha Thoracic Endovascular Graft for the treatment of Blunt Traumatic Aortic Injury (BTAI) Due to the Potential Formation of Thrombus Inside the Device After Implantation 08/16/17
Datascope Corp./MAQUET Recalls Intra-Aortic Balloon Pumps Due to Risk of Valve Failure Preventing Balloon Inflation and Deflation 08/04/17
Oscor Recalls ATAR Reusable and Disposable Extension Cable(s) Due to Risk of Cable Separation from Connector 07/21/17
Penumbra Inc. Recalls 3D Revascularization Device Due to Wire Material That May Break or Separate During Use 07/21/17
Vascular Solutions Inc. Recalls Venture Catheters due to Excess Material that May Split or Separate During Use 06/21/17
Magellan Diagnostics Inc. Expands Recall for LeadCare Testing Systems Due to Inaccurate Test Results 06/05/17
Zimmer Biomet Recalls Implantable Spinal Fusion Stimulators Due to Potential of Harmful Chemicals Which May Be Toxic to Tissues and Organs 05/30/17
Magellan Diagnostics Inc. Recalls LeadCare Plus and Ultra Testing Systems Due to Inaccurate Test Results 05/25/17
Abbott-Thoratec Recalls HeartMate II LVAS Pocket System Controller Due to Risk of Patient Injury and/or Death during Backup Controller Exchange 05/23/17
Respironics California Recalls the V60 Non-invasive Ventilator Due to Faulty Cable Pins That May Cause the Device to Shut Down Unexpectedly 05/22/17
Abbott Vascular Recalls Coronary Catheters Due to Risks Stemming from Difficulty Removing Balloon Sheath 05/19/17
ReFlow Recalls Wingman 35 Crossing Catheters due to Tip Separation 05/15/17
Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.) Expands Recall for Ventricular Assist Device Controllers and DC Adapter 05/04/17
Medtronic Recalls HeartWare Splice Kit Intended to Repair the Driveline of its Ventricular Assist Device Because it May Cause Electrical Issues or Pump Stops 05/04/17
Newport Medical Instruments Inc. Recalls Newport™ HT70 05/02/17
Medtronic Recalls StrataMR Adjustable Valves and Shunts Which May Cause Fluid Buildup in the Brain 04/19/17
Merit Medical Systems, Inc. Recalls the Prelude® Short Sheath Introducer - Sheath May Separate During Use 03/30/17
Phillips Healthcare recalls HeartStart MRx Monitor/Defibrillator due to electrical issues that may prevent the device from operating properly 03/24/17
Medtronic Recalls SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps Due to Failure of Priming Bolus – Update Related to May 2013 Recall 03/14/17
Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator Due to an Electrical Issue Which May Cause the Device to Shut Down Unexpectedly 03/08/17
Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate 02/15/17
Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Failure of Electrical Shock Delivery 02/10/17
CareFusion Recalls Alaris Pump Module due to an Alarm Error Which May Cause Interruption of Therapy 02/08/17
Bard Peripheral Vascular Inc. Recalls Halo One Thin-Walled Guiding Sheath Due to Sheath Separation, Kinking, or Tip Damage 01/30/17
bioMerieux Recalls NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents due to Potential Inaccurate Test Results 01/27/17
Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections 01/03/17

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Page Last Updated: 05/07/2018
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