Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ViaPeel PTFE Peelable Introducer 5FR Recalled by Greatbatch Medical Due to Greatbatch received complaints with the ViaPeel Introducer Sheath...

Date: November 11, 2016
Company: Greatbatch Medical
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Greatbatch Medical directly.

Affected Products

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

Quantity: 5,000 devices

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 1 state: NY

Affected (1 state)Not affected

About Greatbatch Medical

Greatbatch Medical has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report