Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Recalled by St. Jude Medical, Inc. Due to Analysis of the difference between the actual device...
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
Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Quantity: 28,817 devices
Why Was This Recalled?
Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About St. Jude Medical, Inc.
St. Jude Medical, Inc. has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report