St Jude Medical Recalls Fortify ICDs and CRT-Ds for Security Firmware Update
St Jude Medical is recalling Fortify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access. Older devices may require permanent disabling of RF communication.
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 an implanted medical device that could allow unauthorized access, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
St Jude Medical Inc. is recalling 81,338 units of Fortify Sterile EO high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D). The recall is intended to strengthen security by providing an additional layer of protection against unauthorized device access.
The firm is releasing new firmware for these devices to address the security concern. 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 affected devices were distributed nationwide in the U.S. Consumers and healthcare providers should contact St Jude Medical or their device representative for instructions on how to apply the firmware update or disable the RF communication capability.
The recalled product
- Product
- Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD123
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 81,338
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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