Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to Medtronic has become aware of a potential for...
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 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) directly.
Affected Products
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Quantity: 3 units
Why Was This Recalled?
Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 198 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report