St Jude Medical recalls ELLIPSE DR implantable cardioverter defibrillators with damaged aluminum wires that may cause electrical failures. No remedy is provided in this recall notice.
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 specific ELLIPSE DR implantable cardioverter defibrillators (ICDs) due to damaged aluminum wires that could lead to electrical failures. This may prevent the device from delivering life-saving therapy. The recall does not include a remedy.
Damaged aluminum wires in the ICDs may not be fully insulated, increasing the risk of electrical failures. This could prevent the device from delivering high-voltage therapy when needed, potentially leading to serious health consequences.
Patients with implanted ELLIPSE DR cardioverter defibrillators (ICDs) using the specific serial numbers listed are affected. Those with the recalled devices are at risk of the device failing to deliver necessary therapy.
Check if your ELLIPSE DR ICD has a serial number from the list: 1282011, 1282019, 1282065, 1282069, 1282424, 1282458, 1282469, 1282474, 1282596, 1282602, 1282609, 1282622, 1282625, 1282638, 1282641, 1282648, 9829389, 9831310, 9831509, 9831515, 9831516.
Look for the serial number on your ELLIPSE DR ICD to see if it matches the list of affected numbers.
Damaged aluminum wires in the ICDs may not be completely insulated, which could lead to electrical failures and prevent the device from delivering life-saving therapy.
No remedy is provided in this recall notice.
Check if your device's serial number is on the list of affected numbers. If it is, 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-2073-2019 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-2073-2019 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.
