St Jude Medical Recalls Pacemakers for Firmware Security Update
St Jude Medical is recalling 2,726 implantable pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
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 risk-of-harm product (implantable pacemaker) where a security vulnerability (unauthorized access) is identified, but no injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
St Jude Medical Inc. is recalling 2,726 units of the PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP implantable pacemaker pulse generators. These low voltage devices are intended to be permanently implanted in the body to stimulate the heart and correct cardiac rhythm disorders. The recall covers units distributed worldwide.
The recall is being conducted to install new pacemaker firmware. This update was developed to further mitigate the risk of unauthorized access to pacemakers that utilize radio frequency (RF) communications. The source text does not report any specific injuries, illnesses, or deaths associated with this recall.
Patients with these specific devices should contact their healthcare provider or St Jude Medical to discuss the firmware update. The recall notice lists specific serial numbers for the affected units, which can be used to verify if a particular device is included in this action.
The recalled product
- Product
- PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate t
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 2,726
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 10 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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