St Jude Medical recalls ELLIPSE DR defibrillators with damaged aluminum wiring that may cause therapy failure. Affected units have specific serial numbers; contact for remedy.
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 defibrillators due to damaged aluminum wiring that could prevent the device from delivering life-saving shocks. This risk affects patients with implanted devices who rely on the device for heart rhythm management.
Damaged aluminum wiring in the defibrillator could lead to electrical connections that aren't fully insulated. This might prevent the device from delivering necessary high-voltage therapy during emergencies. There's no way to check if the device is vulnerable without a specific test.
Patients with implanted ELLIPSE DR defibrillators are affected. Those who have the specific serial numbers listed in the recall are most at risk.
Check for the serial numbers listed: 9836058, 9836059, 9836061, 9836062, 9836063, 9836064, 9836065, 9836066, 9836067, 9836219, 9836220, 9836221, 9838312, 9838544, 9838546. The device is a cardioverter/defibrillator with the model reference CD2411-36C.
Look for the serial numbers listed in the recall: 9836058, 9836059, 9836061, 9836062, 9836063, 9836064, 9836065, 9836066, 9836067, 9836219, 9836220, 9836221, 9838312, 9838544, 9838546.
The recall states there's a risk of electrical failures that could prevent the device from delivering life-saving therapy, but there's no way to verify if the device is vulnerable without a specific test.
Check the serial number against the list: 9836058, 9836059, 9836061, 9836062, 9836063, 9836064, 9836065, 9836066, 9836067, 9836219, 9836220, 9836221, 9838312, 9838544, 9838546.
The recall states there's no available option to verify the vulnerability status for implanted devices, so 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-2074-2019 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-2074-2019 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.
