St Jude Medical Recalls PM 1260 Assurity+ Pacemakers for Firmware Update
St Jude Medical is recalling 6,051 PM 1260 Assurity+ 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 involves a risk-of-harm product (implantable pacemaker) where the hazard is unauthorized access, but no injuries or illnesses have been reported, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
St Jude Medical Inc. is recalling 6,051 units of the PM 1260 Assurity+ 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 designed to further mitigate the risk of unauthorized access to the devices, which utilize radio frequency (RF) communications. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Consumers with these devices should contact their healthcare provider or St Jude Medical for instructions on how to proceed with the firmware update.
The recalled product
- Product
- PM 1260 ASSURITY + 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 heart. These devices are…
- Manufacturer
- St Jude Medical Inc.
- Affected units
- 6,051
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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