Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Merlin PCS Programmer software model 3330 Recalled by St Jude Medical, Cardiac Rhythm Management Division Due to Devices inappropriately displayed a low battery indicator determined...
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, Cardiac Rhythm Management Division directly.
Affected Products
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
Quantity: 2,906 impacted ICMs
Why Was This Recalled?
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About St Jude Medical, Cardiac Rhythm Management Division
St Jude Medical, Cardiac Rhythm Management Division has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report