---
title: "Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-1... — FDA record Z-1016-2022 | Is It on Recall"
description: "Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia"
url: https://isitonrecall.com/recall/fda-device-z-1016-2022-empower-introducer-sheath-with-hydrophilic-coating-21f-x-56cm-model-668782-100-us/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US) — FDA record Z-1016-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 21, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
- **Reason**: Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
- **Classification**: Class II
- **Recalling firm**: Freudenberg Medical, Llc
- **Quantity**: 13 units (US)
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-1016-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1016-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot Numbers: PD01, PD00013140 UDI: 00850004312001 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US distribution: GA, OH Foreign distribution: Netherlands

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Georgia](https://isitonrecall.com/state/georgia/)
- [Ohio](https://isitonrecall.com/state/ohio/)

## Dates in the source

- **Report date**: May 4, 2022
- **Recall initiation date**: Feb 21, 2022
- **Center classification date**: Apr 28, 2022
- **Termination date**: Apr 18, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1016-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Freudenberg Medical, Llc records](https://isitonrecall.com/brand/freudenberg-medical-llc/)