Medtronic recalls EnTrust Dual Chamber Implantable Cardioverter Defibrillators with potential loss of high voltage therapy as they near replacement indicator. This may cause loss of critical pacing and defibrillation functions. Affected devices have specific serial numbers listed in the recall.
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 (ICDs) that may lose high voltage therapy and anti-tachycardia pacing functions as they approach replacement. This could lead to failure to treat life-threatening arrhythmias. The recall affects specific models with serial numbers listed in the notice.
As these devices approach their replacement indicator (ERI) voltage, they may display an immediate End of Life (EOL) observation without warning. This can cause insufficient battery capacity to charge high voltage circuits, leading to loss of critical pacing and defibrillation therapy.
Patients with implanted EnTrust Dual Chamber ICDs who have specific serial numbers listed in the recall notice are affected. Those at highest risk are patients with atrial tachyarrhythmias or significant risk of developing them.
Check your device's serial number against the list provided in the recall notice. The affected models are Medtronic EnTrust Dual Chamber ICDs with specific serial numbers starting with PNR600... or PNR601... as listed in the recall.
Compare your device's serial number with the list of affected serial numbers provided in the recall notice.
If your device is affected, contact Medtronic directly for further instructions on device replacement or monitoring.
The recall involves Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillators with specific serial numbers listed in the notice.
Check your device's serial number against the list of affected serial numbers provided in the recall notice.
No immediate replacement is required, but affected devices may need monitoring or replacement as recommended by Medtronic.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2417-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2417-2018 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.
