Abbott recalls Proclaim XR 7 implantable pulse generators with possible shorter-than-labeled replacement warning. Affected units may need replacement before expected service end.
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 7 implantable pulse generators that may reach replacement threshold earlier than labeled. This could lead to premature replacement if not addressed.
The pulse generator may reach the need-for-replacement indicator earlier than the product label shows. This could mean replacement happens sooner than intended, potentially affecting device function.
People with Abbott Proclaim XR 7 implantable pulse generators. Those with medical devices requiring regular replacement are most at risk.
Check for the product name 'Abbott Proclaim XR 7 Implantable Pulse Generator' with serial number starting with 05415067031426. The device is sold only by prescription.
Look for the serial number starting with 05415067031426 on the device.
The recall does not specify replacement is needed; it indicates the replacement warning may be shorter than labeled.
The official recall notice does not provide specific action steps beyond checking the serial number.
The device is safe to use as long as the replacement warning 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-2360-2024 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2360-2024 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.
