St Jude Medical recalls Proclaim 5 Elite and Proclaim 7 Elite Implantable Pulse Generators with serial numbers implanted before September 12, 2017. The devices may show inaccurate battery life estimates, potentially leading to unexpected device failure.
Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
St Jude Medical is recalling Proclaim 5 Elite and Proclaim 7 Elite Implantable Pulse Generators with specific serial numbers implanted before September 12, 2017. The recall is due to potential errors in battery life estimation that could lead to unexpected device failure. This does not pose an immediate risk but requires attention to ensure proper device function.
The devices may display inaccurate battery life estimates due to errors in the Clinician Programmer or Patient Controller. This could lead to unexpected device failure if the battery life is misinterpreted, but it does not cause immediate harm.
Patients with Proclaim 5 Elite or Proclaim 7 Elite Implantable Pulse Generators implanted before September 12, 2017, who have the listed serial numbers. The risk is low as the issue relates to battery estimation accuracy rather than immediate safety hazards.
Check if your device has a serial number listed in the provided range (e.g., AAD135.1, AAD136.1, etc.) and was implanted before September 12, 2017. The recall covers specific models and serial numbers.
Identify your device's serial number and compare it to the list of affected serial numbers provided in the recall notice.
If your device is affected, contact St Jude Medical for further instructions on device monitoring or potential replacement.
Proclaim 5 Elite and Proclaim 7 Elite Implantable Pulse Generators with serial numbers implanted before September 12, 2017, as listed in the recall notice.
No action is required if your device's serial number is not listed in the provided range and was implanted after September 12, 2017.
The recall addresses potential battery estimation errors, which could lead to unexpected device failure. However, it does not pose an immediate risk of injury or serious harm.
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-0022-2018 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-0022-2018 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.
