# FDA recall Z-1918-2018

> **LivaNova USA** · Class II · device recall initiated 2018-03-13.

## Product

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 cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 6M 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.

## Distribution

US Distribution to the states of : NJ, CA, MN, MO, MA

## Key facts

- **Recall number:** Z-1918-2018
- **Recalling firm:** LivaNova USA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-13
- **Report date:** 2018-05-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Arvada, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1918-2018

## Citation

> AI Analytics. FDA recall Z-1918-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1918-2018. Source: US FDA. Licensed CC0.

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