LivaNova recalls SMART PERFUSION PACK INSPIRE 8S tubing packs with incorrect cuvette packaging. Affected units have model 046008200 and lot 19121:100141. No remedy specified in recall notice.
“LivaNova SMART PERFUSION PACK INSPIRE 8S: Incorrect Cuvette Packaging Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67501-livanova-smart-perfusion-pack-inspire-8s-incorrect-cuvette-packaging-risk. Based on FDA recall #Z-1389-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1389-2020%22&limit=1).
The FDA announced on July 3, 2019, that LivaNova USA Inc. is recalling the LivaNova SMART PERFUSION PACK INSPIRE 8S because it was packaged with an incorrect cuvette. The agency classified the Class III recall as voluntary and initiated by the firm.
How to tell if you have it
Brand: LivaNova
Product Name: SMART PERFUSION PACK INSPIRE 8S
Model Number: 046008200
Lot Number: 1912100141
UPC: 00803622140136
The hazard
The perfusion tubing pack was packaged with the incorrect cuvette. The product is used in surgical procedures requiring extracorporeal support and includes the cuvette used with equipment to monitor blood.
Context
GovInfoNow's records show LivaNova USA, Inc. has 18 other recalls on record since Jan. 24, 2018. Recent brand recalls include a Jan. 3, 2025 recall of the SenTiva DUO VNS Therapy Generator for risk of stopping therapy and a Dec. 12, 2024 recall of the SenTiva VNS Generator for risk of stopped seizure control. Other recent recalls of similar products include Medtronic Octopus Nuvo Tissue Stabilizer (Jan. 13, 2026), Medtronic Octopus Evolution AS Tissue Stabilizer Model TS2500 (May 12, 2026), and Medtronic Octopus 4 Tissue Stabilizer Model 29400 (May 12, 2026).
How to tell if you have this one
Check for model number 046008200 and lot number 1912100141 on the packaging. The UDI code (01)00803622140136(240)046008200(17)210430(10)1912100141 is also associated with the affected units.
Brand
LivaNova
Product
LivaNova USA Inc. recalls LivaNova SMART PERFUSION PACK INSPIRE 8S
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number (046008200) and lot number (1912100141) on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of IL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1389-2020 (July 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1389-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.