LivaNova USA
LivaNova USA has 4 FDA enforcement events on this register (5 product records) between 2017 and 2018: 4 device; the busiest year was 2018 with 3.
0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in CO.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 9 Nov 2018 | Perfusion Pack, Rx only, Sterile EO | Device | Class II | 1 | Terminated |
| 20 Apr 2018 | Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz | Device | Class II | 1 | Terminated |
| 13 Mar 2018 | Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring… | Device | Class II | 2 | Terminated |
| 19 Dec 2017 | Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO. | Device | Class III | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has LivaNova USA had?
4 enforcement events (5 product records) on this register, 2017–2018: 4 device.
Are any LivaNova USA recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are LivaNova USA recalls?
3 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.