(Washington) – Medtronic is recalling all Implantable Cardiovascular Defibrillators and Cardiac Resynchronization Therapy Defibrillators manufactured after 2017, that have a glass feed through.
The reason for this is because the units might deliver low or no energy output when needed for high voltage therapy and is more likely to be found in devices configured to delivery therapy in the AX>B pathway.
The FDA has identified this as a Class 1 recall since the use of these devices may result in serious injury, serious health consequences, or death.
