---
title: "Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-080... — FDA record Z-1907-2023 | Is It on Recall"
description: "The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 withi"
url: https://isitonrecall.com/recall/fda-device-z-1907-2023-cardiosave-hybrid-intra-aortic-balloon-pumps-iabp-model-number-0998-00-0800-55-part-number-0998-00-0/
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 Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX — FDA record Z-1907-2023

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 May 4, 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 Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
- **Reason**: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
- **Classification**: Class III
- **Recalling firm**: Datascope Corp.
- **Quantity**: 4 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1907-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1907-2023%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 | UDI-DI: 10607567108414; Serial Numbers: CB286971I8 CB283804G8 CB283867G8 CB283522G8 |

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

## Distribution

International distribution in the country of Germany.

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

## Dates in the source

- **Report date**: Jun 21, 2023
- **Recall initiation date**: May 4, 2023
- **Center classification date**: Jun 14, 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-1907-2023%22)

## Related records

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