Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
ELLIPSE VR Recalled by St Jude Medical Inc. Due to Electrical failures were identified in cardioverter defibrillators (ICDs)...
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
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
Quantity: 52
Why Was This Recalled?
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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