# FDA recall Z-0131-2023

> **Datascope Corporation** · Class II · device recall initiated 2022-08-05.

## Product

LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02.  intra-aortic balloon catheter.

## Reason for recall

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.

## 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.

## Key facts

- **Recall number:** Z-0131-2023
- **Recalling firm:** Datascope Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-05
- **Report date:** 2022-11-02

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0131-2023

## Citation

> AI Analytics. FDA recall Z-0131-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0131-2023. Source: US FDA. Licensed CC0.

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