DUBLIN – September 11, 2018 –
Today, Medtronic issued the following statement confirming it has received FDA warning letters (CMS #560736 and #562437) related to its Cardiac Rhythm and Heart Failure facilities located in Mounds View, Minn., and in Juncos, Puerto Rico.
The warning letters reflect earlier FDA inspection reports from spring 2018 related to cardiac defibrillators and contain no new observations. The warning letters do not impact patients or physicians, and no new action is required by them as all potentially affected devices related to this issue were voluntarily recalled in January and March 2018.
There have been no reports of patient death related to the issues identified in the letters. However, Medtronic has confirmed one (1) device failure, which resulted in the loss of device functionality.
In the warning letters, the FDA stated that the Medtronic corrective action plan appears to be adequate to address the issues. At this time, Medtronic does not expect the warning letters to result in material negative financial implications to the Cardiac Rhythm and Heart Failure division or to Medtronic, and the company is working expeditiously to resolve the issues in the warning letters.
Medtronic continues to strive for higher quality throughout the organization by enhancing its systems, processes and accountability, and is committed to the highest quality for its products and therapies. Medtronic is working closely with FDA to resolve the outstanding issues.
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.