Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Isoline Implantable Defibrillation Lead Recalled by Sorin Group USA, Inc. Due to Isoline defibrillation leads distributed may have internal insulation...
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 Sorin Group USA, Inc. directly.
Affected Products
Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
Quantity: 1376 Isoline leads
Why Was This Recalled?
Isoline defibrillation leads distributed may have internal insulation breach.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sorin Group USA, Inc.
Sorin Group USA, Inc. has 52 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report