---
title: "Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbe... — FDA record Z-1277-2023 | Is It on Recall"
description: "There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This"
url: https://isitonrecall.com/recall/fda-device-z-1277-2023-cardiosave-hybrid-intra-aortic-balloon-pump-iabp-model-numbers-model-numbers-0998-00-0800-75-0998-00/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 099... — FDA record Z-1277-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 28, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
- **Reason**: There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
- **Classification**: Class II
- **Recalling firm**: Datascope Corp.
- **Quantity**: 391 total IABPs
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1277-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1277-2023%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Model Number: 0998-00-0800-75, UDI-DI: 10607567112312; Model Number: 0998-00-0800-83, UDI-DI: 10607567108407; Model Number: 0998-00-0800-85, UDI-DI: 10607567113449; Serial Numbers: CA237026J3 CH231276C6 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Distribution list not yet provided.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Mar 29, 2023
- **Recall initiation date**: Feb 28, 2023
- **Center classification date**: Mar 22, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1277-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Datascope Corp. records](https://isitonrecall.com/brand/datascope-corp/)