Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 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
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.
Quantity: 10,453 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