St Jude Medical Recalls Unify ICDs for Security Firmware Update
St Jude Medical is recalling Unify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
St Jude Medical Inc. is recalling 40,738 units of Unify, Sterile EO high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D). The recall is being conducted 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, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059…
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 40,738
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.
See all 12 products in this recall →Related recalls
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