Medtronic recalls EnTrust Escudo D144DRG implantable defibrillators that may lose high voltage therapy as they approach replacement. No remedy stated in official notice.
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 Escudo D144DRG implantable defibrillators that may lose high voltage therapy and anti-tachycardia pacing as they approach replacement. This could cause the device to stop working properly without warning.
As these devices near their replacement indicator, they may display an end-of-life observation without warning. This can cause the device to lose high voltage and anti-tachycardia pacing therapy, potentially stopping life-saving treatment.
People with EnTrust Escudo D144DRG implantable defibrillators (serial numbers listed) who are at risk of losing heart rhythm therapy. This applies to patients with heart conditions requiring defibrillation.
Check if your device has the serial numbers listed in the recall notice (PNR611652S through PNR615003S). The product is an implantable defibrillator for heart conditions.
Review your device's serial number to see if it matches the list of affected units (PNR611652S through PNR615003S).
No action is needed if your device's serial number is not listed in the recall notice.
The official recall notice does not state any remedy or fix for this issue.
Check your device's serial number against the list of affected units (PNR611652S through PNR615003S) provided in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2421-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2421-2018 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.
