Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PM1214 NUANCE SR RF Recalled by St Jude Medical Inc. Due to New pacemaker firmware was developed to further mitigate...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact St Jude Medical Inc. directly.
Affected Products
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 electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
Quantity: 2741 units
Why Was This Recalled?
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Where Was This Sold?
Worldwide Distribution
About St Jude Medical Inc.
St Jude Medical Inc. has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report