Medtronic recalls EnTrust single-chamber ICDs with atrial and ventricular therapies that may lose high voltage therapy as battery nears end of life, risking sudden loss of life-saving pacing.
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 single-chamber implantable cardioverter defibrillators that may lose critical heart rhythm therapy as the battery nears end of life. This could cause sudden loss of life-saving pacing if the device fails without warning.
The device may display an immediate End of Life (EOL) observation without warning when battery capacity is low. This could cause sudden loss of high voltage therapy needed for life-saving heart rhythm pacing, especially if the device fails without prior alert.
People with Medtronic EnTrust single-chamber ICDs that have the specific serial numbers listed in the recall notice are affected. Those with the device nearing end-of-life battery capacity are at highest risk.
Check for the specific serial numbers: PNT402938H, PNT413911H, or PNT413995H on your device. The product was sold with the model number D153VRC.
Identify your device's serial number to confirm if it matches the recalled numbers: PNT402938H, PNT413911H, or PNT413995H.
Medtronic has become aware that the device may lose high voltage therapy as battery capacity nears end of life, potentially causing sudden loss of life-saving pacing without warning.
The device may display an immediate End of Life (EOL) observation without prior warning, leading to loss of high voltage therapy needed for heart rhythm pacing.
Check for the specific serial numbers: PNT402938H, PNT413911H, or PNT413995H on your device. The product was sold with model number D153VRC.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2418-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2418-2018 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.
