Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of LivaNovaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list LivaNova USA with 48 device recalls and 3 510(k) clearances. The most recent is a 510(k) clearance dated Mar 11, 2026: Venous Return Cannulae.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 11, 2026 | Venous Return CannulaeK250937 · DWF | 510(k) clearances |
| Jul 10, 2025 | RAP Femoral Venous CannulaeK250283 · DWF | 510(k) clearances |
| Aug 8, 2024 | SMARxT Tubing and ConnectorsK233702 · DWE | 510(k) clearances |
| Nov 9, 2018 | Perfusion Pack, Rx only, Sterile EOClass II · 4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical proce | Device recalls |
| Apr 20, 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, 1Class II · Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler | Device recalls |
| Mar 13, 2018 | Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute thClass II · Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identi | Device recalls |
| Mar 13, 2018 | Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute theClass II · Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identi | Device recalls |
| Dec 19, 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, IncClass III · The product is labeled with the incorrect expiration date. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
