---
title: "LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. int... — FDA record Z-0131-2023 | Is It on Recall"
description: "The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result"
url: https://isitonrecall.com/recall/fda-device-z-0131-2023-linear-7-5fr-40cc-iab-with-accessories-apa-model-no-0684-00-0480-02-intra-aortic-balloon-catheter/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter. — FDA record Z-0131-2023

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 Aug 5, 2022. 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**: LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
- **Reason**: The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.
- **Classification**: Class II
- **Recalling firm**: Datascope Corporation
- **Quantity**: 4414 OUS
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0131-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0131-2023%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: 10607567106571 Lot codes: 3000210759 3000210758 3000203002 3000198455 3000144227 3000142368 3000141069 3000140532 3000134522 3000130423 3000126591 |

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

## Distribution

No US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Columbia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Pakistan, Poland, Portugal, South Korea, Russia, Spain, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay.

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

## Dates in the source

- **Report date**: Nov 2, 2022
- **Recall initiation date**: Aug 5, 2022
- **Center classification date**: Oct 24, 2022

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-0131-2023%22)

## Related records

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