St Jude Medical recalls Ellipse cardioverter defibrillators with specific serial numbers that may lose wireless communication with doctors, preventing remote monitoring. Affected devices require immediate attention.
Past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication; which means patients can no longer be interrogated with wireless RF telemetry or monitored remotely.
St Jude Medical is recalling certain Ellipse cardioverter defibrillators that may lose wireless communication with healthcare providers due to software updates. This means patients could no longer be monitored remotely, which is critical for managing heart conditions.
Past software updates to the device's programmers and transmitters can cause some implantable cardioverter defibrillators to lose wireless radiofrequency communication. This prevents healthcare providers from remotely monitoring the device or checking the patient's heart rhythm.
Patients with implanted cardioverter defibrillators (ICDs) using the recalled Ellipse models are most at risk. These devices are typically used for life-threatening heart rhythm issues.
Check if your Ellipse device has the specific serial numbers listed in the recall notice (e.g., 1138400, 1138406, etc.) or the UDI/GTIN codes mentioned in the product details.
Look for the serial number on your device's label or documentation to confirm if it's in the list of affected numbers provided in the recall.
Reach out to your doctor or healthcare provider to discuss the recall and get guidance on next steps for your specific device.
No, but you should check if your device is affected and contact your healthcare provider for guidance.
If your device loses wireless communication, healthcare providers cannot monitor your heart rhythm remotely, which could lead to missed health issues.
Check the serial number on your device against the list of affected numbers provided in the recall notice.
We’ve drafted a message you can send St Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1351-2020 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-1351-2020 from St Jude Medical. 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.
