# FDA recall Z-1385-2018

> **Datascope Corporation** · Class II · device recall initiated 2018-02-21.

## Product

Intra-Aortic Balloon Catheter Mega 8FR 50cc  Product Usage:  The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

## Reason for recall

The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-1385-2018
- **Recalling firm:** Datascope Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-21
- **Report date:** 2018-04-25
- **Termination date:** 2020-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fairfield, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1385-2018

## Citation

> AI Analytics. FDA recall Z-1385-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1385-2018. Source: US FDA. Licensed CC0.

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