Events

Recall of Device Recall ViaPeel PTFE Peelable Introducer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Greatbatch Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76701
  • Event Risk Class
    Class 2
  • Event Number
    Z-2781-2017
  • Event Initiated Date
    2016-11-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153933
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Introducer, catheter - Product Code DYB
  • Reason
    Greatbatch received complaints with the viapeel introducer sheath 5fr, of handles detaching during use.
  • Action
    Consignee was sent via email on 11/11/2016 a Greatbatch "Urgent Medical Device Recall" letter dated November 2016. The letter described the product involved in the recall, Reason for Field Corrective Action, Risk to Health, Replacement Devices & Instructions to Customer. Advised consignees to quarantine the product, contact end users & complete and return the Field Recall Response Form to Stericycle at Greatbatch7893@stericycle.com or fax at 888-473-8015. For questions contact your local Greatbatch Medical representative, contact us at 1-763-951-8235, or e-mail us at FieldActionCenter@Greatbatch.com

Device

Device Recall ViaPeel PTFE Peelable Introducer
  • Model / Serial
    Lot Number: W3101005
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    NY
  • Product Description
    ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Manufacturer Address
    Greatbatch Medical, 2300 Berkshire Ln N, Plymouth MN 55441-4575
  • Manufacturer Parent Company (2017)
    Integer Holdings Corporation
  • Source
    USFDA