# FDA recall Z-1687-2022

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

## Product

Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter

## Reason for recall

Certain lots containing undersized dilator.

## Distribution

Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-1687-2022
- **Recalling firm:** Datascope Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-05
- **Report date:** 2022-09-14

- **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-1687-2022

## Citation

> AI Analytics. FDA recall Z-1687-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1687-2022. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*