FDA Device recall Z-1389-2020
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requir…
- FDA Device
- Class III
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class III recall of LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requir… by Livanova Usa, citing perfusion tubing pack was packaged with the incorrect cuvette.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1389-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-07-03 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Livanova Usa |
| Distribution | US |
Product
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
Reason
Perfusion tubing pack was packaged with the incorrect cuvette.
Identifiers
| code_info | Model Number: 046008200 Lot Number: 1912100141 UDI: (01)00803622140136(240)046008200 (17)210430(10)1912100141 Cuv…Model Number: 046008200 Lot Number: 1912100141 UDI: (01)00803622140136(240)046008200 (17)210430(10)1912100141 Cuvette Component P/N 03016 - SAT/HCT B-care 5 cuvette |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Livanova Usa
- SenTiva, REF: 1000
FDA Device · Class II · 2025-02-12 · Livanova Usa - SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation
FDA Device · Class II · 2025-02-12 · Livanova Usa - Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: T…
FDA Device · Class II · 2025-02-05 · Livanova Usa - Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product De…
FDA Device · Class II · 2025-02-05 · Livanova Usa - Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303
FDA Device · Class II · 2022-02-09 · Livanova Usa
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1389-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.