Medical Device Recalls in 2017 - The Lyon Firm
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Medical Device Recalls in 2017

Medical Device Recalls in 2017: Specific Devices Linked to Failure and Injury

Technological advancements in medical devices can greatly influence the quality of life for thousands of ailing American consumers. When devices are deemed necessary, doctors, health care providers and patients rely on the good judgment, honesty, and expertise of medical device manufactures to offer safe products.

Unfortunately, manufacturers and distributors may be negligent and offer defective devices, causing further injury and complications. If medical devices are inadequately tested, and sold with dangerous defects, medical device companies may be held liable for injuries that result. In many cases medical device recalls try to preempt injuries, but unlike many consumer products, surgically implanted devices are difficult to recall and revise. Revision surgeries are not uncommon and may merit legal counsel.

A list of medical devices recalls from 2017 includes the following:

  • Physio-Control Inc. Defibrillation Electrodes—Incorrect placement instructions for infants depicted on artwork
  • OriGen Biomedical Medical Reinforced Dual Lumen ECMO Catheter—Separation concerns
  • Jude Medical Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)—Premature battery depletion
  • Spectranetics Corp. Bridge Occlusion Balloon Catheter—Risk of blocked guidewire preventing balloon utilization
  • Leonhard Lang Multi-function Defibrillation—Electrode malfunction
  • Datascope Corp./MAQUET Intra-Aortic Balloon Pumps—False blood detection alarm and ingress of fluid into the Intra-Aortic Balloon Pump
  • Cook Medical Inc. Zenith Alpha Thoracic Endovascular Graft—Potential formation of thrombus inside the device after implantation
  • Datascope Corp./MAQUET Intra-Aortic Balloon Pumps—Risk of valve failure preventing balloon inflation and deflation
  • Oscor ATAR Reusable and Disposable Extension Cable—Risk of cable separation from connector
  • Penumbra Inc. 3D Revascularization Device—Wire material may break or separate during use
  • Vascular Solutions Inc. Venture Catheters—Excess material may split or separate during use
  • Magellan Diagnostics Inc. LeadCare Testing Systems—Inaccurate test results
  • Zimmer Biomet Implantable Spinal Fusion Stimulators—Potential of harmful chemicals which may be toxic to tissues and organs
  • Magellan Diagnostics Inc. LeadCare Plus and Ultra Testing Systems—Inaccurate test results
  • Abbott-Thoratec HeartMate II LVAS Pocket System Controller—Risk of patient injury and/or death during Backup Controller Exchange
  • Respironics California V60 Non-invasive Ventilator—Faulty cable pins that may cause the device to shut down unexpectedly
  • Abbott Vascular Coronary Catheters—Risks stemming from difficulty removing Balloon Sheath
  • ReFlow Wingman 35 Crossing Catheters—Tip separation
  • Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.) Ventricular Assist Device Controllers and DC Adapter
  • Medtronic HeartWare Splice Kit Intended to Repair the Driveline of its Ventricular Assist Device—May cause electrical issues or Pump Stops
  • Newport Medical Instruments Inc. Newport™ HT70
  • Medtronic StrataMR Adjustable Valves and Shunts—May cause fluid buildup in the brain
  • Merit Medical Systems, Inc. Prelude® Short Sheath Introducer—Sheath may separate during use
  • Phillips Healthcare HeartStart MRx Monitor/Defibrillator—Electrical issues may prevent the device from operating properly
  • Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps—Failure of Priming Bolus
  • Physio-Control Inc. LIFEPAK 1000 Defibrillator—Electrical issue may cause the device to shut down unexpectedly
  • Zimmer Biomet Comprehensive Reverse Shoulder—High Fracture Rate
  • Physio-Control LIFEPAK15 Monitor/Defibrillator—Failure of electrical shock delivery
  • CareFusion Alaris Pump Module—Alarm Error may cause interruption of therapy
  • Bard Peripheral Vascular Inc. Halo One Thin-Walled Guiding Sheath—Sheath separation or tip damage
  • bioMerieux NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents—Inaccurate Test Results
  • Nurse Assist Inc. Normal Saline Flush IV Syringes—Possible Burkholderia Cepacia bloodstream infections

If you or a loved one has suffered an injury due to a defective medical device  and have questions about the legal remedies available to improve quality of life and medical care, or want to learn more about medical device recalls, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.

Contact us today.