St Jude Medical Recalls 101 Implantable Pacemakers for Firmware Update
St Jude Medical is recalling 101 implantable pacemaker pulse generators 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 high-risk medical device (implantable pacemaker) where a security vulnerability (unauthorized access) poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
St Jude Medical Inc. is recalling 101 units of the PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST 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 with specific serial numbers listed in the agency record.
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.
Patients with these specific devices should contact their healthcare provider or St Jude Medical for instructions on how to proceed with the firmware update.
The recalled product
- Product
- PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST 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 the
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 101
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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