Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ellipse Recalled by St Jude Medical, Cardiac Rhythm Management Division Due to Past updates to programmers and transmitters may lead...
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, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330
Quantity: 256
Why Was This Recalled?
Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.
Where Was This Sold?
This product was distributed to 19 states: AZ, CA, DE, FL, IN, KY, MD, MI, MS, MO, NJ, NY, NC, OH, OK, PA, TX, WA, WV
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