---
title: "MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-... — FDA record Z-0311-2025 | Is It on Recall"
description: "There is discrepant labeling on the inner and outer packaging of the device."
url: https://isitonrecall.com/recall/fda-device-z-0311-2025-mega-7-5fr-40cc-intra-aortic-balloon-with-accessories-model-number-0684-00-0295-01/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 — FDA record Z-0311-2025

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 Sep 17, 2024. 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**: MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
- **Reason**: There is discrepant labeling on the inner and outer packaging of the device.
- **Classification**: Class II
- **Recalling firm**: Datascope Corp.
- **Quantity**: 160 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0311-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0311-2025%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: 10607567107974; Lot Number: 3000344298 |

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

## Distribution

International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.

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

## Dates in the source

- **Report date**: Nov 13, 2024
- **Recall initiation date**: Sep 17, 2024
- **Center classification date**: Nov 5, 2024

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-0311-2025%22)

## Related records

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