St Jude Medical Recalls ZENEX Pacemakers for Firmware Update
St Jude Medical is recalling 4,828 ZENEX pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
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 3/5 (High).
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 is classified as FDA Class II and involves a risk-of-harm product (unauthorized access to an implantable medical device) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
St Jude Medical Inc. is recalling 4,828 units of PM 1250, PM 2250, PM1282, and PM2282 ZENEX MRI 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 affected units were 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.
Patients with these specific pacemaker models should contact their healthcare provider or St Jude Medical to schedule the firmware update. The recall is classified as FDA Class II.
The recalled product
- Product
- PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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…
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 4,828
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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