St Jude Medical Recalls Fortify Assura ICDs for Security Firmware Update
St Jude Medical is recalling Fortify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a security vulnerability (unauthorized access) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
St Jude Medical Inc. is recalling 131,093 units of Fortify Assura implantable cardiac devices, including implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The recall covers specific model and part numbers distributed nationwide in the United States.
The recall is being conducted to release new firmware intended to strengthen the security of these high-voltage devices. The update provides an additional layer of protection against unauthorized device access. For older generation devices that cannot accept the new firmware, the firm is advising customers of the option to permanently disable the RF communication capability.
Healthcare providers and patients with these specific devices should contact St Jude Medical or their healthcare provider for instructions on how to obtain the firmware update or disable the RF communication capability.
The recalled product
- Product
- 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; CD1263-40/10004294
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 131,093
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by St Jude Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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