Medtronic HVAD Systems Carry Pump Malfunction Risk, FDA Warns
The pump malfunction risk is the latest problem with Medtronic HVAD systems, which were removed from the market last year due to rampant defects and patient deaths.
The pump malfunction risk is the latest problem with Medtronic HVAD systems, which were removed from the market last year due to rampant defects and patient deaths.
Investigators have yet to identify the cause of the airway obstruction risks linked to the silicone-based Medtronic EMG endotracheal tubes.
Following reports of capsules breaking, hundreds of Medtronic Harmony Delivery Catheters have been recalled due to the risk of patient injury and death.
The MiniMed 630G pump was recalled in November 2019, just months before plaintiff's husband went into an insulin-induced coma and died.
The FDA received HVAD injury and death reports, and sent Medtronic warning letters, as early as 2014, but did not take significant action until a 2021 recall
Medical device manufacturers have done little to close cybersecurity gaps in infusion pumps and other vulnerable machines, even after years of experts warning about hacking risks
Concerns over problems with Medtronic MiniMed pumps malfunctioning led to a recall in February 2020.
The FDA warns devices affected by the Medtronic TurboHawk catheter recall could cause serious, life-threatening injuries to patients if the catheter tip breaks off.
The JPML rejected a request to consolidate the cases in 2020, at which time there were only 12 Covidien mesh lawsuits filed. Now that number has increased to 73, with thousands of additional claims expected.
Plaintiff was required to carry an external plastic bag from which he had to empty his bowel contents for four months.