LivaNova recalls specific Perfusion Packs (Rx only, sterile) due to potential leaks or blockages in surgical tubing systems used for up to six hours of extracorporeal support.
4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded.
LivaNova is recalling certain Perfusion Packs (Rx only, sterile) that may leak or become blocked during surgical procedures requiring up to six hours of extracorporeal support. This could lead to complications in critical medical treatments.
The stopcocks and stopcock manifold in certain perfusion tubing systems may leak or become blocked during use. This could disrupt blood flow or fluid management in critical surgical procedures requiring up to six hours of extracorporeal support.
Medical professionals using these Perfusion Packs for surgical procedures requiring extracorporeal support for up to six hours are most at risk. Patients receiving this treatment may be affected if the device fails.
Check the lot numbers listed in the recall: 1819000027, 1813500044, 1809300053, and other specific numbers provided in the recall notice. These Perfusion Packs are intended for surgical use only and require sterile conditions.
Verify if your Perfusion Pack has a lot number listed in the recall (e.g., 1819000027, 1813500044, etc.).
The recall indicates potential leaks or blockages, so it is not safe to use without checking the lot numbers. The product is intended for surgical procedures only.
The recall does not specify a remedy, so contact LivaNova USA directly for guidance on next steps.
Check the lot number against the list provided in the recall notice (e.g., 1819000027, 1813500044, etc.).
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-0770-2019 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-0770-2019 from LivaNova. 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.
