Abbott Medical recalls Proclaim Plus 7 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 Plus 7 implantable pulse generators that may have a shorter service life than labeled. This could mean replacement is needed sooner than intended, potentially affecting patient safety.
The pulse generator may reach the replacement indicator threshold earlier than the product label suggests. This could lead to the device needing replacement sooner than planned, potentially affecting patient safety.
Patients with Abbott Proclaim Plus 7 implantable pulse generators who received this model. Those with the specific serial numbers listed in the recall are most at risk.
Check for the serial number 05415067046406 on the device. This model is sold under the Abbott Proclaim Plus 7 Implantable Pulse Generator, REF : 3672, Sterile EO, Rx Only.
Look for the serial number 05415067046406 on the device.
The recall does not specify an immediate replacement requirement. Affected units may need replacement sooner than labeled, but the exact timing depends on individual patient needs.
Check the device serial number. If it matches 05415067046406, contact Abbott Medical for further instructions.
The recall indicates a potential shorter service life than labeled, but it does not describe a specific hazard that could cause injury. The danger 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-2366-2024 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2366-2024 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.
