Events

Recall of Device Recall ClosureFast Micro Introducer Sheath Set

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

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
    73376
  • Event Risk Class
    Class 2
  • Event Number
    Z-1029-2016
  • Event Initiated Date
    2016-02-17
  • Event Date Posted
    2016-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143987
  • 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
    Dilator, vessel, for percutaneous catheterization - Product Code DRE
  • Reason
    The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.
  • Action
    On February 17, a letter was sent to Medtronic notifying them of a voluntary recall.

Device

Device Recall ClosureFast Micro Introducer Sheath Set
  • Model / Serial
    Lot 1125585 (MIS-F707) Lot 11126021 (IS-7F11)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in IL.
  • Product Description
    ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. || Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
  • Manufacturer
    Argon Medical Devices, Inc

Manufacturer

Argon Medical Devices, Inc