Abbott Medical recalls Proclaim 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 Proclaim 5 implantable pulse generators that may have a shorter service life than labeled. This could mean the device needs replacement sooner than intended, potentially affecting patient safety.
The device may reach its replacement indicator threshold earlier than the label suggests. This could lead to the device needing replacement sooner than intended, potentially affecting patient safety.
Patients with Abbott Proclaim 5 implantable pulse generators are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check your Abbott Proclaim 5 pulse generator's serial number. Affected units have the serial numbers 05415067023247.
Look for the serial number on your Abbott Proclaim 5 pulse generator to confirm if it's affected.
The recall indicates a potential shorter service life than labeled, but it does not state that the device causes injury or death.
Check the serial number on your Abbott Proclaim 5 pulse generator. Affected units have the serial number 05415067023247.
The recall does not specify a replacement requirement; it only indicates a potential shorter service life than labeled.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2362-2024 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2362-2024 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.
