LivaNova recalls SORIN Heater-Cooler System 3T models with potential disinfectant inefficiency and aerosol emission risks. Affected units may need repair or replacement to ensure patient safety during medical procedures.
The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. In addition, the firm is releasing a design upgrade to reduce the risk of potential emission of aerosols from the 3T.
LivaNova is recalling SORIN Heater-Cooler System 3T medical devices due to a risk that the disinfectant may become ineffective, potentially allowing microorganisms to grow. This could lead to infections during surgeries if the device is not properly maintained. The recall also includes a design upgrade to reduce aerosol emissions.
The disinfectant/water preservative in the device may become ineffective due to a chemical reaction, allowing microorganisms to grow. Additionally, the design upgrade aims to reduce the risk of aerosol emissions that could pose respiratory hazards during medical procedures.
Patients undergoing heart surgery using the SORIN Heater-Cooler System 3T are most at risk. Healthcare facilities that use this specific medical device for extracorporeal perfusion are affected.
Check for the model number 3T with voltage specifications listed in the product description. Affected units include specific serial numbers ranging from 16S10027 to 16S16847 for the 120V/60Hz version.
Identify the model number and voltage specifications on the device label to confirm if it's affected.
Reach out to LivaNova for guidance on the next steps if the device is confirmed affected.
The firm has become aware that the disinfectant/water preservative may become ineffective due to a chemical reaction, potentially allowing microorganisms to grow. This could lead to infections during medical procedures.
The affected units include the SORIN Heater-Cooler System 3T with serial numbers from 16S10027 to 16S16847 for the 120V/60Hz version.
Yes, LivaNova is releasing a design upgrade to reduce the risk of potential aerosol emissions, but the specific remedy is not detailed in the recall notice.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-0220-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-0220-2020 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.
