St Jude Medical Recalls Unify Assura ICDs for Security Firmware Update
St Jude Medical is recalling Unify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a security vulnerability in a high-risk medical device (implantable cardiac defibrillator) where injury has not yet been reported, fitting the rubric for risk-of-harm products without reported illness.
Plain-English summary
St Jude Medical Inc. is recalling 65,048 units of Unify Assura Sterile EO implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D). The recall is initiated to release new firmware intended to strengthen security by providing an additional layer of protection against unauthorized device access.
The affected devices were distributed nationwide in the U.S. For older generation devices that are not capable of accepting the new firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
The recalled product
- Product
- Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 65,048
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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