St Jude Medical Recalls Nuance Pacemakers for Firmware Update
St Jude Medical is recalling 2,741 Nuance pacemakers to install new firmware that mitigates the risk of unauthorized access to the devices' 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 addresses a risk-of-harm product (implantable pacemaker) where the hazard is unauthorized access, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
St Jude Medical Inc. is recalling 2,741 units of PM1214 NUANCE SR RF, PM1230 and PM2230 NUANCE MRI, and PM2214 NUANCE DR RF implantable pacemaker pulse generators. These low-voltage devices are intended to be permanently implanted in the body to produce periodic electrical pulses that stimulate the heart, serving as a substitute for the heart's intrinsic pacing system to correct cardiac rhythm disorders.
The recall is being conducted to install new pacemaker firmware designed to further mitigate the risk of unauthorized access to pacemakers that utilize radio frequency (RF) communications. The affected devices were distributed worldwide.
Patients with these specific pacemaker models 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.
The recalled product
- Product
- PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF 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…
- Manufacturer
- St Jude Medical Inc.
- Hazard
- Affected units
- 2,741
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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