St Jude Medical recalls ELLIPSE VR implantable cardioverter defibrillators with damaged aluminum wires that may cause electrical failures. No verification method available for vulnerable devices.
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
St Jude Medical is recalling ELLIPSE VR implantable cardioverter defibrillators (ICDs) with damaged aluminum wires that could lead to electrical failures. This may prevent the device from delivering life-saving shocks during cardiac emergencies. Affected devices have specific serial numbers listed in the recall.
Damaged aluminum wires in the ICDs may not be properly insulated, creating electrical connections that could fail. This might prevent the device from delivering necessary high-voltage therapy during cardiac emergencies. There is no way to check if a specific device is vulnerable.
People with ELLIPSE VR ICDs (serial numbers listed) who are at risk due to potential electrical failures. Patients with heart conditions requiring these devices are most affected.
Check if your ELLIPSE VR ICD has a serial number from the list: 1281828, 1281840, 1282688, 1282724, 1282734, 1283113, 1283627, 1283633, 1283634, 1283639, 1283641, 1283643, 1283646, 1283648, 1283656, 1283657, 1283659, 1283660, 1283672, 1283680, 1283681, 1283683, 1283689, 1283690, 1283692, 1283695, 1283697, 1283703, 1283704, 1283708, 1283742, 1283747, 1283749, 1283766, 1283772, 1283780, 1283783, 1283784, 1283788, 1283832, 1283838, 1283845, 1283868, 1283884, 9831441, 9831445, 9831759.
Look for the serial number on your ELLIPSE VR ICD device to see if it matches the list of affected numbers provided in the recall.
No, there is no available option to verify the vulnerability status for implanted devices.
The recall does not specify a remedy, so you should contact St Jude Medical directly for guidance.
The potential impact could be the inability to deliver high voltage therapy during cardiac emergencies.
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-2071-2019 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-2071-2019 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.
