Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Optisure Dual Coil Defibrillation Leads Recalled by St Jude Medical Cardiac Rhythm Management Division Due to Leads may have been compromised during the manufacturing...
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
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
Quantity: 447 units total (281 units in US)
Why Was This Recalled?
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
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