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Top Defective Medical Devices for 2019


The year is just half over, but the number of defective products on the Food and Drug Administration’s list of 2019 Medical Device Recalls is already alarmingly high. The FDA maintains an annual register for all medical products that were recalled due to dangerous defects, either by the manufacturer or government officials. On average, there are around three dozen every year; in 2018, there were 32 medical device recalls.

If you suffered harm because of a dangerous product in the health care setting, it’s important to discuss your rights with a Florida defective products lawyer. You can also learn some critical information by reviewing the top devices recalled so far for 2019.

  1. Medtronic’s Synergy Cranial Software: This technology is used by neurosurgeons to obtain 3D images of a patient’s brain, thereby ensuring safe navigation of the tools used in surgery. The software was providing incorrect information to physicians during procedures, potentially leading to harm to the patient. This first recall of 2019 was classified by the FDA as a Class I – the most serious type of recall that could cause life-threatening injuries or death.
  1. Draeger Medical’s Anesthesia Sets: This equipment is used during surgery when the patient is under general anesthesia, where it’s necessary to provide ventilation and breathing support. Some units were incorrectly assembled when attached to an anesthesia machine, potentially leading the device to short-circuit or otherwise malfunction. With lack of breathing support, the patient could suffer oxygen deprivation to the brain, stroke, or death.
  1. Medtronic’s Implantable Pulse Generators: These devices, used to stimulate heart rate, incorporate a battery and other electronic components. The recall is based upon a software error that disrupts the normal functioning of heart rate pacing. A patient could experience abnormal heartbeat, low blood pressure, fainting, and even death as a result of the defect.
  1. Roche Diagnostics Test Strips: Used to monitor a patient’s response to the blood-thinner warfarin, these strips work by obtaining blood from the finger. When inserted into a meter, the strips measure the time it takes for blood to clot – an indicator that warfarin is having its intended effect. The recall is due to the fact that the results delivered by the strips were inaccurate when compared to lab tests. As a result, a patient might not receive the accurate dose of warfarin.
  1. Terumo Medical Corporation SoloPath Balloon System: The most recent medical device recall also fell into the Class I category. The device is a balloon that helps a physician insert and guide placement of catheters, reducing friction during the process and minimizing pain to the patient. However, the tip of the device could become dislodged and eliminate the smooth surface, resulting in tears to blood vessels, hemorrhage, and other injuries.

Call Now to Speak with a Skilled Florida Defective Products Attorney 

To learn more about your legal options in a defective medical device case, please contact Freidin Brown, P.A. to set up a complimentary consultation. We serve clients throughout Southern Florida from our offices in Miami or Fort Myers.



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