St Jude Medical recalls ELLIPSE DR cardioverter defibrillators with damaged aluminum wires that may cause electrical failures. Affected devices could fail to deliver life-saving therapy. No verification option exists for implanted 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 DR cardioverter defibrillators due to damaged aluminum wires that could cause electrical failures. This may prevent the device from delivering necessary life-saving therapy. Affected devices have specific serial numbers listed in the recall notice.
Damaged aluminum wires in the device may not be properly insulated, creating electrical failures. This could prevent the device from delivering high-voltage therapy when needed, potentially causing life-threatening situations.
Patients with implanted ELLIPSE DR cardioverter defibrillators are affected. Those with the listed serial numbers are most at risk.
Check if your ELLIPSE DR device has a serial number from the list: 9829846, 9829991, 9830102, 9830495, 9830497, 9831323, 9831461, 9831788, 9831792, 9831793, 9831899, 9831902, 9833544, 9833845, 9833847, 9833852, 9833930, 9834097, 9834099, 9834102, 9834107, 9834110, 9834115, 9834117, 9834118, 9834119, 9834121, 9834124, 9834207, 9834211, 9834217, 9834357, 9834385, 9834535, 9834536, 9834669, 9834820, 9834952, 9834954, 9834955, 9835491, 9835786.
Immediately stop using the ELLIPSE DR cardioverter defibrillator if it has a serial number from the list provided in the recall.
Damaged aluminum wires in the device may not be properly insulated, creating electrical failures that could prevent the device from delivering life-saving therapy.
Check if your ELLIPSE DR device has a serial number from the list: 9829846, 9829991, 9830102, 9830495, 9830497, 9831323, 9831461, 9831788, 9831792, 9831793, 9831899, 9831902, 9833544, 9833845, 9833847, 9833852, 9833930, 9834097, 9834099, 9834102, 9834107, 9834110, 9834115, 9834117, 9834118, 9834119, 9834121, 9834124, 9834207, 9834211, 9834217, 9834357, 9834385, 9834535, 9834536, 9834669, 9834820, 9834952, 9834954, 9834955, 9835491, 9835786.
Immediately stop using the device and contact St Jude Medical for further instructions.
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-2075-2019 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-2075-2019 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.
