# FDA recall Z-2781-2017

> **Greatbatch Medical** · Class II · device recall initiated 2016-11-11.

## Product

ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006

## Reason for recall

Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use.

## Distribution

NY

## Key facts

- **Recall number:** Z-2781-2017
- **Recalling firm:** Greatbatch Medical
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-11-11
- **Report date:** 2017-08-09
- **Termination date:** 2017-11-03

- **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-2781-2017

## Citation

> AI Analytics. FDA recall Z-2781-2017. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2781-2017. Source: US FDA. Licensed CC0.

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