FDA Recalls More Defective Medical Devices - The Lyon Firm
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FDA Recalls More Defective Medical Devices

Ohio Product Liability Attorneys Reviewing FDA Recalls of Device Defects


Serious injuries and deaths may result from medical device defects, and the U.S. Food and Drug Administration (FDA) works to protect consumers to the best of their ability. When manufacturers, surgeons or patients report injury related to specific devices, the FDA may issue a warning or a recall, depending on the seriousness of the defect and the risk it poses to American consumers. Recently, the FDA recalled the following defective medical devices:

  • Medtronic’s HeartWare Ventricular Assist Device (HVAD)
  • Maquet Datascope Corp.’s CARDIOSAVE Hybrid intra-aortic balloon pumps (IABP)
  • Abbott’s HeartMate 3 Left Ventricular Assist System
  • Draeger Medical Jaundice Meters

FDA Recalls: Health Risks Lead to Warnings and Recalls

Each year, millions of medical devices are found defective and the FDA recalls what they deem dangerous to the public. Many recalled products are released in Ohio under a pre-approval process and are never properly tested until they lead to injuries, and perhaps only recalled after the companies face product liability lawsuits.

The FDA regularly recalls devices when they determine that the product is hazardous or violates FDA law. Recent FDA Recalls include:

  • Class I Recall issued June 1, 2018: HeartWare Ventricular Assist Device (HVAD): risk for serious injuries or death, because of the possibility of interruption in the electrical connection between the system’s power source and the HVAD controller.
  • Class I Recall for all CARDIOSAVE Hybrid intra-aortic balloon pumps (IABP) manufactured since December 2011 because of a design flaw that allows fluid such as saline to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death. The CARDIOSAVE Hybrid Intra-aortic Balloon Pump is a cardiac assist device used with patients undergoing cardiac and non-cardiac surgery.
  • Class I FDA Recall of the Abbott HeartMate 3 Left Ventricular Assist System because of risk associated with problems with the device’s outflow graft assembly which may lead to graft occlusion. Such occurrence can lead to serious adverse events including blood clots and death.
  • FDA Recall of Draeger Medical Jaundice Meters over issues with users misinterpreting the display. The recall is due to users misinterpreting a blinking “-0-” as a zero measurement, and operating the device and delivering care based on that reading. The device is intended for use in hospitals to assist clinicians in monitoring of newborn infants.

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

Contact us today.