Abbott Medical recalls Proclaim 7 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 Medical is recalling Proclaim 7 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 earlier than the label suggests. This could mean the device needs replacement sooner than intended, potentially causing complications if it fails.
People with Abbott Proclaim 7 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 your Abbott Proclaim 7 pulse generator's serial number. The recall covers units with the serial numbers listed in the record (05415067020239).
Look for the serial number on your Abbott Proclaim 7 pulse generator to confirm if it's affected.
The recall does not require immediate replacement. The device may need earlier replacement than labeled, but the exact timing depends on individual circumstances.
Check your serial number against the list provided in the recall. If affected, contact Abbott Medical for further instructions.
The recall indicates a potential for earlier replacement than labeled, but it does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2361-2024 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2361-2024 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.
