Abbott recalls Proclaim XR 5 implantable pulse generators with shorter-than-labeled replacement warning. Affected units may need earlier replacement to prevent complications.
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 is recalling Proclaim XR 5 implantable pulse generators that may require earlier replacement than labeled. This could lead to complications if the device fails before the intended replacement time.
The device may reach the replacement indicator threshold sooner than the product label suggests. This could mean the device needs replacement earlier than intended, potentially causing complications.
People with Abbott Proclaim XR 5 implantable pulse generators who have a prescription for the device. Those with the specific serial numbers listed in the recall are most at risk.
Check the serial number on your device. Affected units have the UDI: 05415067031419 and all serial numbers listed in the recall.
Look for the UDI: 054:15067031419 on your device's label.
The recall does not require immediate replacement. The device may need replacement earlier than labeled, but the exact timing depends on individual use.
Check your device's serial number against the list provided in the recall. If it matches, contact Abbott Medical for further instructions.
The device is safe to use as long as it is functioning properly and the replacement indicator is not reached earlier 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-2358-2024 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2358-2024 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.
