# FDA recall Z-2218-2023

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

## Product

TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta    Product Description                                                    Part Number    7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES	D684-00-0545-01  TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES	D684-00-0546-01  TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES	D684-00-0607  TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES	D684-00-0608  PACKAGED INSERTION KIT - TRANS-RAY 7 Fr. 34/40 cc IABs	D884-00-0019-18  PACKAGED INSERTION KIT - TRANS-RAY PLUS 7.5 Fr. 35/40 IABs	D884-00-0019-26

## 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-2218-2023
- **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-2218-2023

## Citation

> AI Analytics. FDA recall Z-2218-2023. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2218-2023. Source: US FDA. Licensed CC0.

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