Events

Recall of miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. || General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Miramar Labs, 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
    72386
  • Event Risk Class
    Class 2
  • Event Number
    Z-0234-2016
  • Event Initiated Date
    2015-10-09
  • Event Date Posted
    2015-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140877
  • 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
    Instrument for treatment of hyperhidrosis - Product Code OUB
  • Reason
    Update to labeling for the miradry console to remind users to only use approved lubricants in a thin layer to prevent potential burns and blisters.
  • Action
    Miramar Labs sent Medical Device Correction letters to all users on October 9, 2015 to inform them of the labeling clarification by UAPS First Class Certified mail or courier such as Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the firm added a new warning to their labeling. The firm included an updated copy of the MD4000-MC User Manual with the new warning included and asked that customers destroy their older copy. Customers with questions were instructed to call Customer SService at 1-855-647-2379 or email info@miraDry.com

Device

miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD40...
  • Model / Serial
    MN-MD4000-MC, all units
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. || General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.
  • Manufacturer
    Miramar Labs, Inc.

Manufacturer

Miramar Labs, Inc.
  • Manufacturer Address
    Miramar Labs, Inc., 2790 Walsh Ave, Santa Clara CA 95051-0963
  • Manufacturer Parent Company (2017)
    Sientra Inc.
  • Source
    USFDA