# FDA recall Z-0933-2020

> **Datascope Corporation** · Class II · device recall initiated 2019-11-20.

## Product

Reinforced Introducer Sets  Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.

## Reason for recall

Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets   Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.

## Distribution

US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV    OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia

## Key facts

- **Recall number:** Z-0933-2020
- **Recalling firm:** Datascope Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-20
- **Report date:** 2020-02-12
- **Termination date:** 2021-06-15

- **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-0933-2020

## Citation

> AI Analytics. FDA recall Z-0933-2020. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0933-2020. Source: US FDA. Licensed CC0.

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