LivaNova recalls six units of SORIN Heater-Cooler System 3T (REF 16-02-85) due to post-deep cleaning water testing positive for nontuberculous mycobacteria. Affected units have specific serial numbers.
For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
LivaNova is recalling six units of the SORIN Heater-Cooler System 3T (REF 16-02-85) because water samples after deep cleaning tested positive for nontuberculous mycobacteria. This could pose a health risk if the system is used in medical procedures.
The water sample tested positive for nontuberculous mycobacteria after deep cleaning. This type of bacteria can cause infections in medical settings, though the risk is low for most users.
Patients using the SORIN Heater-Cooler System 3T with a Stockert/Sorin heart-lung machine may be affected. Medical staff handling these units are most at risk.
Check for serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877 on the unit. The product is intended for use with specific heart-lung machines.
Look for the specific serial numbers listed: 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.
The post-deep cleaning water sample tested positive for nontuberculous mycobacteria in six units.
Six units with specific serial numbers: 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.
Check the serial number against the list provided. If it matches, contact LivaNova for further instructions.
We’ve drafted a message you can send LivaNova to request your refund or repair — edit it as you like.
Subject: Recall Z-1099-2019 — LivaNova LivaNova Hello, I own a LivaNova that is covered by recall Z-1099-2019 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.
