Medtronic recalls EnTrust Escudo D144VRC implantable defibrillators (OUS distribution) due to potential loss of high voltage therapy as devices near replacement indicator. No ERI alert may trigger an immediate End of Life observation, risking loss of critical heart rhythm treatment.
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 specific models of EnTrust Escudo implantable defibrillators (D144VRC) that may lose high voltage therapy as they approach replacement. This could lead to failure of life-saving heart rhythm treatment without warning. Affected devices have unique serial numbers listed in the recall.
As the device approaches its replacement indicator (ERI), battery voltage may drop below safe levels. Without an ERI alert, the device could display an immediate End of Life observation, causing loss of high voltage therapy and anti-tachycardia pacing. This may result in the device failing to treat life-threatening heart rhythms.
Patients with Medtronic EnTrust Escudo D144VRC implantable defibrillators (OUS distribution) who have the listed serial numbers are affected. Those with the device nearing replacement indicator are at highest risk.
Check if your device has the serial numbers listed in the recall (e.g., PNT608737S, PNT608738S, etc.). The product is an implantable defibrillator used for heart rhythm treatment.
Review your device's serial number against the list of affected units provided in the recall notice.
Reach out to Medtronic directly for guidance on next steps if your device is affected.
The Medtronic EnTrust Escudo D144VRC (OUS distribution) implantable defibrillator.
Check if your device has a serial number listed in the recall (e.g., PNT608737S, PNT608738S, etc.).
Contact Medtronic directly for guidance on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2420-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2420-2018 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.
