Events

Recall of MiraDry System

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
    58853
  • Event Risk Class
    Class 2
  • Event Number
    Z-2591-2011
  • Event Initiated Date
    2011-04-24
  • Event Date Posted
    2011-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100417
  • 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
    Reports of skin burns on axilla after treatment with the miradry system.
  • Action
    The firm,Miramar, has a service provider in Japan that assists in dealing with customers. The service providers were provided a copy of the investigation report and communicated directly with the customers to set up appointments for the field correction. The customers were personally visited by a representative from Miramars service provider in Japan. All devices had field correction performed on April 26-28, 2011.

Device

MiraDry System
  • Model / Serial
    Serial numbers: 10H0158, 10H0160, 10H0161, 10H0167, 10H0172, 10H0185, 10H0193, 11H0035.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International only: Japan
  • Product Description
    MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece || (MD3001-HP), the miraDry biotip and the miraDry Treatment Template system. || Miramar Labs, Inc. || 445 Indio Way || Sunnyvale, CA 94085 || Intended use: Treatment of primary axillary hyperhidrosis.
  • Manufacturer
    Miramar Labs, Inc.

Manufacturer

Miramar Labs, Inc.
  • Manufacturer Address
    Miramar Labs, Inc., 445 Indio Way, Sunnyvale CA 94085-4203
  • Manufacturer Parent Company (2017)
    Sientra Inc.
  • Source
    USFDA