Abbott Medical recalls Proclaim 7 implantable pulse generators with shorter-than-labeled replacement warning. Affected units may need earlier replacement to avoid risks.
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 7 implantable pulse generators because the device may reach its replacement threshold sooner than labeled. This could lead to earlier need for replacement than expected.
The pulse generator may reach its replacement indicator threshold earlier than the product label shows. This could mean the device needs replacement sooner than intended, potentially leading to earlier need for replacement.
People with an implanted Proclaim 7 pulse generator who received this specific model. Those with the device may need earlier replacement.
Check for the serial number 05415067023254 on the device. This model is sold with a specific reference number (REF 3667) and is a sterile, prescription-only implantable pulse generator.
Look for the serial number 054:15067023254 on the device.
No, the recall does not require immediate stop use. The device may need earlier replacement than labeled, but it is not unsafe to use.
Check the device serial number. If it matches 05415067023254, contact Abbott Medical for guidance on replacement.
The device may need replacement sooner than labeled, but it is not unsafe to use. The hazard level is low risk.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2363-2024 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2363-2024 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.
