St Jude Medical Recalls Unify Quadra ICDs for Security Firmware Update
St Jude Medical is recalling Unify Quadra 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 (ICD/CRT-D) where injury has not yet been reported, fitting the rubric for risk-of-harm products.
Plain-English summary
St Jude Medical Inc. is recalling 22,132 units of Unify Quadra high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D). The recall is intended to release new firmware that strengthens security by providing an additional layer of protection against unauthorized device access.
The affected devices were distributed nationwide in the United States. 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 Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 22,132
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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