# FDA recall Z-2435-2023

> **Datascope Corp.** · Class I · device recall initiated 2023-07-31.

## Product

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65

## Reason for recall

Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing).  Blood in the circuit, kins and abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms.  The HHE also identified hardware issues related to these alarms.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-2435-2023
- **Recalling firm:** Datascope Corp.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-31
- **Report date:** 2023-09-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2435-2023

## Citation

> AI Analytics. FDA recall Z-2435-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2435-2023. Source: US FDA. Licensed CC0.

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