Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Merlin PCS 3650 programmer Model 3330 software Recalled by St. Jude Medical, Cardiac Rhythm Management Division Due to Due to a programmer software anomaly under very...
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 3650 programmer Model 3330 software
Quantity: 30,069 devices with software
Why Was This Recalled?
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
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 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report