Z-2591-2011

MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraDry biotip and the...

Name: Z-2591-2011 MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraDry biotip and the...
Creator: Miramar Labs, Inc.
Published: 2011-04-24
License: https://open.fda.gov/license/

miraDry, Inc. / initiated 2011-04-24 / Terminated / root cause: design

FDA source

Miramar Labs, Inc. began a recall of MiraDry System consisting of the DTS3000 Console, MiraDry Handpiece (MD3001-HP), the miraDry biotip and the miraDry Treatment Template system. Miramar Labs... on 2011-04-24. The reason FDA records is "Reports of skin burns on axilla after treatment with the miraDry System". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2591-2011
Status: Terminated
Initiated: 2011-04-24
Posted: 2011-06-17
Terminated: 2011-06-17
Recalling firm: miraDry, Inc.
Product: 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.
Product code: OUB Instrument For Treatment Of Hyperhidrosis
Reason for recall: Reports of skin burns on axilla after treatment with the miraDry System.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 8 units
Distribution: International only: Japan
Product codes and lots: Serial numbers: 10H0158, 10H0160, 10H0161, 10H0167, 10H0172, 10H0185, 10H0193, 11H0035.

Product code OUB

K103014Class IIMiradry SystemMiramar Labs, Inc. / cleared 2011-01-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)