Abbott Medical recalls Proclaim Plus 5 implantable pulse generators with shorter-than-labeled service life. Affected units have serial numbers starting with 05415067046390. Contact Abbott for replacement.
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
Abbott Medical is recalling Proclaim Plus 5 implantable pulse generators that may have a shorter service life than labeled. This could lead to premature replacement needs if the device fails before the intended service period.
The device may reach its replacement indicator threshold earlier than the product label states. This means the device might need replacement sooner than expected, potentially leading to earlier replacement needs.
People with a Proclaim Plus 5 implantable pulse generator who received this specific model from Abbott Medical. Those with the serial numbers starting with 0541:5067046390 are most at risk.
Check for the serial number starting with 05415067046390 on your Abbott Proclaim Plus 5 implantable pulse generator. This model is only available with a sterile, prescription-only label.
Look for the serial number starting with 05415067046390 on your device.
Reach out to Abbott Medical for replacement options if you have the affected serial number.
The device may reach its replacement indicator threshold earlier than the product label states, potentially requiring earlier replacement.
Check your serial number starting with 05415067046390 and contact Abbott Medical for replacement options.
The recall is for potential premature replacement needs, not an immediate risk of serious injury.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2365-2024 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2365-2024 from Abbott 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.
