Recall Z-2321-2018 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
St Jude Medical Inc.
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-4
| Date | Apr 16, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 preferen |
| Quantity | 131093 |
| Distribution | U.S. Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.