Medtronic recalls EnTrust dual-chamber ICDs with potential loss of heart therapy as battery capacity drops near replacement. Affected devices may show end-of-life warnings without prior alerts.
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.
Medtronic is recalling certain EnTrust dual-chamber implantable cardioverter defibrillators that may lose heart therapy as battery capacity decreases near replacement. This could lead to a loss of critical pacing and defibrillation functions if the device fails to alert before battery depletion.
As the device's battery nears the end of its life, it may lose high voltage and anti-tachycardia pacing therapy without warning. This could happen even if the device shows no end-of-life alert, potentially causing the device to stop working when needed.
Patients with Medtronic EnTrust ICDs who have the specific serial numbers listed in the recall are affected. Those with atrial tachyarrhythmias or significant risk of developing them are most at risk.
Check your device's serial number against the list provided in the recall. The affected models include EnTrust Dual Chamber ICDs with specific serial numbers starting with PNR100502Q through PNR100270Q.
Compare your device's serial number to the list of affected serial numbers provided in the recall.
Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo ICDs as battery capacity decreases near replacement.
The recall does not require replacement; it only asks you to check your device's serial number against the list to ensure it is affected.
If the device loses therapy, it may not be able to treat life-threatening arrhythmias, which could be serious but is not guaranteed to cause immediate harm.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2416-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2416-2018 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
