Class II — LivaNova USA
| Recalling firm | LivaNova USA, Inc. |
|---|---|
| Registered facility | LivaNova USA, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Perfusion Pack, Rx only, Sterile EO |
| Quantity | 483 |
| Distribution | Worldwide Distribution - Domestic (US) Consignees: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV, MS; Foreign (OUS) Consignees: Canada |
| Initiated | 2018-11-09 |
| Classified | 2019-01-23 |
| Terminated | 2022-05-03 |
| Recall number | Z-0770-2019 |
| 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 (Z-0770-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81667/
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