The Food and Drug Administration (FDA) recently inspected the Mounds View, Minn., location of Medtronic’s heart implant division and found problems with the company’s procedures for “preventing and identifying problems with its devices, documenting those problems, and the speed with which it informs the FDA of any issues,” says a report by the Associated Press. Medtronic says they are already planning corrections to the facility. They have 15 days to respond to the FDA warning and company spokespersons say they have already taken measures to address and correct the problems. The FDA announced that they feel the corrections are sufficient to fix the problems.
Medtronic is no stranger to FDA safety alerts and recalls about multiple products manufactured by the company.
In 2008, Medtronic’s AneuRX abdominal stent graft system was linked to more deaths than open surgery for the same purpose; preventing rupturing of swollen vessels that supply blood to the abdomen. However, Medtronic’s company spokesperson, Daniel Beach, said that “based on the highest-quality data available, AneuRX performs better compared to open surgery in late abdominal aortic aneurysms related deaths. He also said that the FDA’s analysis relies on “average mortality risk from surgery rather than a controlled clinical study.”
In another case, Medtronic informed the FDA and clinics worldwide that it had received reports of infusion system difficulties that were attributed to an improper alignment between the catheter’s connector and the pump’s port in heart surgeries. Another problem cited with the same product was a disconnection of the catheter from the pump. The recall was referred to as a Class 1 recall, means the problems or defect could serious injure or kill patients. Medtronic’s investigation claimed the events were caused by misalignments or incomplete connections of the catheter during the implant procedure.
Just last May, the company faced a recall of thousands of its pacemakers due to a wiring defect that made them unresponsive or caused them to run out of battery power. The recall was also deemed a Class 1 recall. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. The affected pacemakers are the Kappa Series 600/700/900 and the Sigma Series 100/200/300. There are more than 1.7 million Kappa or Sigma pacemakers implanted in patients throughout the world. About 21,000 of those are affected by the recall.