# FDA recall Z-1016-2022

> **Freudenberg Medical, Llc** · Class II · device recall initiated 2022-02-21.

## Product

Empower Introducer Sheath with Hydrophilic Coating  21F x 56cm  Model: 668782-100 (US)

## Reason for recall

Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to  peripheral ischemia

## Distribution

US distribution: GA, OH  Foreign distribution: Netherlands

## Key facts

- **Recall number:** Z-1016-2022
- **Recalling firm:** Freudenberg Medical, Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-02-21
- **Report date:** 2022-05-04
- **Termination date:** 2024-04-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jeffersonville, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1016-2022

## Citation

> AI Analytics. FDA recall Z-1016-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1016-2022. Source: US FDA. Licensed CC0.

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