St Jude Medical Recalls Ellipse ICDs for Security Firmware Update
St Jude Medical is recalling Ellipse ICDs and CRT-Ds 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: The recall is classified as FDA Class II and addresses a security vulnerability (unauthorized access) without reported injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
St Jude Medical Inc. is recalling Ellipse Sterile EO implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D). The recall involves 139,351 units distributed nationwide in the U.S.
The firm is releasing new firmware intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices that cannot accept the firmware, the firm is advising customers of the option to permanently disable the RF communication capability.
Customers should contact St Jude Medical for instructions on applying the firmware update or disabling the RF communication capability on affected devices.
The recalled product
- Product
- Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 139,351
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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