St Jude Medical recalls ELLIPSE VR implantable cardioverter defibrillators with damaged aluminum wires that could fail to deliver life-saving shocks. No fix available; affected units have specific serial numbers.
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 may not be properly insulated. This could prevent the device from delivering critical life-saving shocks during emergencies.
The ICDs have damaged aluminum wires that may not be fully insulated. This could cause electrical failures preventing the device from delivering high-voltage therapy when needed for life-threatening heart rhythms.
People with ELLIPSE VR ICDs (serial numbers listed) who have the device implanted. Those with the specific serial numbers are most at risk.
Check if your ELLIPSE VR ICD has a serial number from the list provided: 9831140, 9831656, 9834078, 9834079, 9834084, 9834177, 9834184, 9834187, 9834307, 9834319, 9834322, 9834323, 9835098, 9835106, 9835107, 9835351, 9835354, 9835356, 9835768, 9835769, 9835771, 9835914, 9835916, 9837174, 9837251, 9837256, 9837606.
Review your ELLIPSE VR ICD's serial number against the list of affected units provided in the recall notice.
The recall notice states there is no available option to verify the vulnerability status for implanted devices, so no fix is provided.
Check if your ELLIPSE VR ICD has a serial number from the list: 9831140, 9831656, 9834078, 9834079, 9834084, 9834177, 9834184, 9834187, 9834307, 9834319, 9834322, 9834323, 9835098, 9835106, 9835107, 9835351, 9835354, 9835356, 9835768, 9835769, 9835771, 9835914, 9835916, 9837174, 9837251, 9837256, 9837606.
The recall does not specify a stop-use instruction; the hazard is not described as causing immediate risk in normal use.
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-2070-2019 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-2070-2019 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.
