Inspire 8 Integrated Phisio OXY w/ HVR Reservoir — Class II medical device recall Z-1919-2018
Terminated recall by LivaNova USA, reported 2018-05-30, distributed in CA, MA, MN, MO, NJ. Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Dev
| Recall number | Z-1919-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LivaNova USA, Arvada, CO, United States |
| Recall initiated | 2018-03-13 |
| Classified | 2018-05-23 |
| Reported by FDA | 2018-05-30 |
| Distributed | CA, MA, MN, MO, NJ |
| Quantity | 70 |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 08033178112369 |
| Lot numbers | 1709190230, 1710260210 |
| Model numbers | 050714 |
| Expiration dates | 2020-09-17, 2020-10-24 |
Product
Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenator: The INSPIRE 8M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 8M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less.
Reason for recall
Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1919-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.