# FDA recall Z-2110-2023

> **Abbott** · Class I · device recall initiated 2023-06-12.

## Product

Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

## Reason for recall

There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during  procedures in which the ASDS product was used.

## Distribution

Worldwide distribution - US Nationwide and the countries of Slovakia,  Czech Republic.

## Key facts

- **Recall number:** Z-2110-2023
- **Recalling firm:** Abbott
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-12
- **Report date:** 2023-07-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2110-2023

## Citation

> AI Analytics. FDA recall Z-2110-2023. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2110-2023. Source: US FDA. Licensed CC0.

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