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Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy

Medtronic is recalling Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Resynchronization Therapy Defibrillators (CRT-Ds) after receiving reports that some devices have triggered short circuit protection (SCP) alerts during the second phase of high voltage waveform therapy and delivered reduced-energy electric shocks.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

Questions?

Customers with questions or concerns about this recall should contact Medtronic Technical Services (1-800-723-4636) or their local Medtronic representative.