Medtronic recalls EnTrust single-chamber implantable cardioverter defibrillators with atrial and ventricular therapies that may lose high voltage therapy as they approach replacement indicator. No ERI alert is triggered but battery may not have enough capacity to charge circuits, causing loss of therapy.
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 EnTrust single-chamber implantable cardioverter defibrillators that may lose high voltage therapy as they approach replacement. The device may show an immediate End of Life (EOL) observation without warning, leading to loss of critical pacing and defibrillation functions.
As the device's battery nears the end of its life, it may display an immediate End of Life (EOL) observation without prior warning. This can cause the device to lose high voltage and anti-tachycardia pacing therapy, which is critical for treating life-threatening heart rhythms. The battery may not have enough capacity to charge the high voltage circuits, leading to a loss of function.
Patients with Medtronic EnTrust single-chamber ICDs (model numbers listed in the recall) who are nearing replacement. The risk is highest for those with the device's battery capacity dropping below the threshold for high voltage therapy.
Check if your device has a serial number starting with PNT6000 (e.g., PNT600036S) or the product UPN/GTIN 00885074300276. The recall includes specific serial numbers listed in the notice.
Look for the device's serial number on the back of the device or in the patient's medical records. If it starts with PNT6000 (e.g., PNT600036S), it is affected.
If your device is affected, contact Medtronic directly at 1-800-833-2222 or via their website to schedule a replacement.
Medtronic has identified a potential risk that the device may lose high voltage therapy as it approaches replacement indicator without warning, which could lead to loss of critical pacing and defibrillation functions.
No, but you should contact Medtronic to schedule a replacement before the device's battery capacity drops too low.
Check your device's serial number. If it starts with PNT6000 (e.g., PNT600036S), it is affected. The recall includes specific serial numbers listed in the notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2419-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2419-2018 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.
