# FDA recall Z-2224-2023

> **Datascope Corp.** · Class II · device recall initiated 2023-06-23.

## Product

REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                                                            Part Number  REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr.	D684-00-0403-05  REINFORCED INTRODUCER SET FOR SENSATION 7Fr.	D684-00-0403-06  REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr.	D684-00-0403-10

## Reason for recall

During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath.  Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

## Distribution

Domestic distribution nationwide. International distribution worldwide.

## Key facts

- **Recall number:** Z-2224-2023
- **Recalling firm:** Datascope Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-23
- **Report date:** 2023-08-02

- **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-2224-2023

## Citation

> AI Analytics. FDA recall Z-2224-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2224-2023. Source: US FDA. Licensed CC0.

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