Abbott Medical recalls Proclaim 5 Elite Implantable Pulse Generators with serial numbers starting 05415067020192 due to potential shorter-than-labeled service life. Affected devices 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 Elite Implantable Pulse Generators with specific serial numbers because the device might reach its end of service sooner than the label says. This could mean the device needs replacement earlier than intended, which is important for patients relying on this medical device.
The device may reach its end of service earlier than the label indicates, meaning it could need replacement sooner than expected. This could lead to potential complications for patients who rely on the device for medical treatment.
Patients with a Proclaim 5 Elite Implantable Pulse Generator who own the recalled serial numbers are most at risk. The recall affects individuals using this specific medical device under a prescription.
Check the serial number on your Proclaim 5 Elite Implantable Pulse Generator. The recalled units have serial numbers starting with 05415:067020192.
Look for the serial number on your device, which starts with 05415067020192.
The device may reach its end of service sooner than the label indicates, which could mean it needs replacement earlier than expected.
Check the serial number on your Proclaim 5 Elite Implantable Pulse Generator; affected units have serial numbers starting with 05415067020192.
The recall does not require immediate action, but you should check the serial number to see if your device is affected.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2369-2024 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2369-2024 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.