Medtronic Inc., the world’s largest medical technology company, announced on November 18 that it received a warning letter from the U.S. Food and Drug Administration following an inspection of the company’s heart implant division.
After an August inspection of the Mounds View, Minnesota, Cardiac Rhythm Disease Management facility (which makes makes implantable pacemakers and defibrillators), the FDA identified certain shortcomings in the company’s procedures for preventing and identifying issues with the heart rhythm devices and letting regulators know about any of those problems. The federal agency also cited quality control issues for suppliers.
The warning letter has yet to be posted on the FDA’s website. However, according to the Wall Street Journal, “the FDA said reports and field actions involving wiring issues with certain pacemakers aren’t being completed in a consistent manner, among other issues.”
A statement on Medtronic’s website indicates the company has already started taking corrective action to shore up its internal systems. “Medtronic remains committed to providing the highest quality products to our customers and is working with FDA to resolve all remaining issues as quickly as possible,” Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic, said. The company has 15 days to formally respond to the FDA’s letter.
Separately, Medtronic has previously been subject to several FDA-imposed medical device recalls.
If you have any questions about your legal rights in relation to Medtronic pacemaker recalls, do not hesitate to contact the lawyers at the Law Offices of Richard J. Serpe, P.C. for a no-obligation consultation, Toll Free 877-544-5323.