The FDA has issued a Class I Recall for possible fracture risks of Medtronic Defibrillator Leads. The recall comes one day after the company issued a warning of possible fracture dangers and voluntarily stopped distribution of suspected products. The FDA says that fracture risks can be associated with a very small percentage of manufactured leads however they are taking fast and furious action. Medtronic Inc.’s Sprint Fidelis Defibrillator Leads are said to be linked to five deaths and I am sure this number will only increase as more and more people look back at past events.
On Monday, Minneapolis-based Medtronic disclosed that the Sprint Fidelis wires have fractured in about 2.3% of the 268,000 models made, 235,000 of which are still implanted in people.
Plaintiff’s attorneys have already begun filing lawsuits against the company and Iowa Senator Chuck Grassley is leading a charge to investigate the leads in question. With all of the heat that the FDA has received over the past couple of years it is likely that the FDA will bear the brunt of the scrutiny over its oversight of the defect in the leads. They do not want another Kugel Mesh on their hands; however, I think that is just what this could turn out to be.
Medtronic said in a statement that when it “had the appropriate information to make a decision regarding the Sprint Fidelis defibrillation lead, we did so … with patient safety and well being as our primary concern.”
For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.