The U.S. FDA has issued a Class 1 recall, the most serious type of recall, on the SynchroMed infusion pump manufactured by Medtronic Inc. Our Pearland medical device recall attorneys mention that a Class 1 recall means that the defective medical device poses risks of serious injury or death to patients.
The SynchroMed Implantable Infusion System, an implantable medical device intended to deliver pain medications and other drugs to patients, was found to contain four defects that have led to at least 14 deaths. The most frequent harm to patients resulted from inadvertent injection of the medications into the patients’ subcutaneous tissue rather than into the pump. Our Pearland medical device recall attorneys sadly report that one patient also died from an electrical short in the SynchroMed device, and two died from blockages.
Additionally, use of the SynchroMed priming bolus to move drugs quickly from the pump to the tip of the catheter causes the medicines to mix with sterile water or cerebrospinal fluid, which can either dilute the drug or result in an overdose. The SynchroMed infusion pump could also stall or not properly deliver drugs to patients.
Contact the Pearland Medical Device Recall Attorneys at Denena Points, PC to Report Injury or Death from a Medtronic Product
Our goals are to see that the U.S. FDA receives reports of serious injuries or deaths linked to defective medical devices as soon as possible to alert the agency to the need for product recalls, and to help injured patients and their family members receive just compensation after they’ve suffered needless harm from a defective product. Contact us right away at 281-369-4363 or fill out our online report form to report a serious injury to yourself or your loved one. Let our veteran medical device injury attorneys help you win the full financial recovery you deserve after a needless injury from a defective medical device.
Several Major Medtronic Products have been Linked to Serious Injuries or Deaths
Our Pearland medical device recall attorneys note that another of Medtronic’s major products, Infuse, the spinal fusion product used to treat patients with bone deterioration in the lower back, was linked to severe side effects and complications. Medtronic was found to have paid over $200 million for the research studies and papers published in medical journals that depicted Infuse in a positive light.
An investigation of these payments by the Senate Committee on Finance reportedly found that Medtronic improperly manipulated, influenced, and/or collaborated with the authors of the studies to create a positive impression of the Infuse implant that was not warranted by the actual results of using the product.
And Medtronic, the largest maker of cardiac medical devices, was also sued over its defective defibrillators. Our Pearland medical device recall attorneys point out that the company settled that case for $268 million. Click the link to read more about the Medtronic defibrillator lawsuit and the settlement awarded for aggrieved patients and their family members.