Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906

The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.

On 04/16/2018, Important Medical Device Advisory notifications were mailed via overnight service to U.S. physicians and hospitals notifying customers of the availability of the programmer software update and associated ICD/CRT-D firmware update. Advisory notifications were mailed to customers outside the U.S. on different dates depending on geography and local regulatory requirements. Prophylactic replacement of affected devices is not recommended. The firm recommends firmware upgrades for all eligible patients at the next regularly scheduled visit or when appropriate depending on the preferences of the patient and physician. For devices not eligible for the cybersecurity firmware update the firm recommends a discussion of the risks of cybersecurity vulnerabilities and proven benefits of remote monitoring with patients at their next regularly scheduled visit. RF communication may be permanently disabled in devices not eligible for firmware updates during an in-clinic device interrogation with a programmer that has received the software update. Customers with questions about the firmware update can call the customer technical support hotline at 1-800-436-5056.