Class II — LivaNova USA Inc.
| Recalling firm | LivaNova USA, Inc. |
|---|---|
| Registered facility | LivaNova USA, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The Stckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: " Two circuits for the patient supplied by one tank (for the heating/cooling blanket and the heat-exchanger associated with the oxygenator), common temperatures ranging from 2 degrees Celsius to 41 degrees Celsius, tank volume 6 liters. " One interchangeable heating/cooling circuit for cardioplegia heat-exchanger, temper… |
| Quantity | 8671 |
| Distribution | Worldwide distribution - US Nationwide distribution including sate of PR and countries of Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Guatem… |
| Initiated | 2018-11-01 |
| Classified | 2019-10-25 |
| Terminated | 2022-08-04 |
| Recall number | Z-0220-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — LivaNova USA Inc. (Z-0220-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83822/
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