LivaNova recalls Heater-Cooler 3T systems for potential NTM contamination during cardiopulmonary bypass procedures. Follow cleaning instructions to reduce risk.
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
LivaNova is recalling its Heater-Cooler 3T systems used in heart surgery to reduce the risk of NTM (non-tuberculous mycobacteria) contamination. This recall addresses a potential risk during short surgeries where the system circulates water to warm or cool patients.
The system circulates water through heat exchangers to warm or cool patients during heart surgery. If not properly cleaned, it could allow NTM bacteria to grow, potentially causing infections in patients.
Patients undergoing heart surgery with the LivaNova Heater-Cooler 3T system for procedures under six hours. Medical teams using the system are most at risk.
Check for model numbers 16S10027 to 16S16874 (230V), 16S10743 to 16S11708 (240V), 16S10772 to 16S16840 (208V), 16S11455 to 16S16509 (127V), or 16S10958 to 16S16847 (120V), or 16S12004 to 16S16818 (200V). These units were sold between 2016 and 2023.
Follow LivaNova's updated cleaning and disinfection procedures to reduce NTM contamination risk.
LivaNova is providing updated cleaning instructions to reduce the risk of NTM contamination during heart surgery procedures.
The recall record does not specify what NTM is.
Check your serial numbers against the ranges listed: 16S10027 to 16S16874 (230V), 16S10743 to 16S11708 (240V), 16S10772 to 16S16840 (208V), 16S11455 to 16S16509 (127V), 16S10958 to 16S16847 (120V), or 16S12004 to 16S16818 (200V).
No, the recall does not require stopping use; updated cleaning instructions are provided to reduce risk.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-1498-2020 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-1498-2020 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.
