Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ellipse Implantable Cardioverter Defibrillators (ICDs) Recalled by St Jude Medical Cardiac Rhythm Management Division Due to An anomaly may result in delayed, partial, or...
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
Quantity: 51,492 units (27,396 units in US)
Why Was This Recalled?
An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. It may present as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert.
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 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report