St Jude Medical Recalls Implantable Cardiac Devices for Security Firmware Update
St Jude Medical is recalling 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 medical devices that could allow unauthorized access, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
St Jude Medical Inc. is recalling 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 recall affects 71,651 units 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
- Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 600107
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 71,651
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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