Abbott Medical recalls Proclaim Plus 5 implantable pulse generators with shorter-than-labeled service life. Affected units may need replacement sooner than expected.
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 certain Proclaim Plus 5 implantable pulse generators because they may reach replacement needs sooner than labeled. This could lead to unplanned replacements before the intended service period ends.
The pulse generator may reach the end of its service life earlier than the label indicates. This could mean replacement is needed sooner than planned, potentially causing unplanned medical procedures.
People with a Proclaim Plus 5 implantable pulse generator who received this specific model. Those with the device may need earlier replacement than expected.
Check for the model number REF 367: 05415067046383 on the device. This recall affects specific serial numbers only.
Look for the serial number 05415067046383 on the device to confirm if it's affected.
The recall indicates the device may need replacement sooner than labeled, but immediate action isn't required. Check your serial number first.
Contact Abbott Medical to confirm if your device is affected and get guidance on next steps.
This recall is about potential shorter service life, not an immediate safety risk like injury or malfunction.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2364-2024 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2364-2024 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.
