# FDA recall Z-0725-2018

> **Terumo Medical Corporation** · Class II · device recall initiated 2017-09-12.

## Product

Destination Guiding Sheath catheter introducer, Catalog Number: RSR06    Product Usage:  The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.

## Reason for recall

The tucking depth feature of this catheter introducer is marginally outside the upper specification.

## Distribution

To be added.

## Key facts

- **Recall number:** Z-0725-2018
- **Recalling firm:** Terumo Medical Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-12
- **Report date:** 2018-03-07
- **Termination date:** 2018-08-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elkton, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0725-2018

## Citation

> AI Analytics. FDA recall Z-0725-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0725-2018. Source: US FDA. Licensed CC0.

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